Infant Omega-3 Supplementation Tied to Decreased Waist Size

In continuation of my update on Omega-3 fatty acids

Omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation in infancy is associated with reduced insulin concentrations and insulin resistance in boys and reduced waist circumference in both sexes at age 5 years, according to a study published online June8 in Pediatrics.

Valene H.L. See, Ph.D., from the Royal Perth Hospital in Australia, and colleagues randomly assigned 420 infants to a daily supplement of n-3 LCPUFA or olive oil (control) from birth to 6 months. Growth, body composition, and cardiometabolic risk factors were evaluated at 5 years of age.

The researchers found that infants who received n-3 LCPUFA had a smaller waist circumference at 5 years (coefficient, 1.1 cm), which remained significant after adjusting for confounders (coefficient, 0.8 cm). Boys who received n-3 LCPUFA supplementation had a 21 percent reduction in insulin concentrations and a 22 percent reduction in insulin resistance versus the control group. At birth, 2.5 years, and 5 years, there were no other differences in growth and cardiometabolic risk factors between the groups.

"Longer-term follow-up of the cohort is warranted to determine whether these differences are maintained into adolescence," write the authors

Infant Omega-3 Supplementation Tied to Decreased Waist Size..

In continuation of my update on Omega-3 fatty acids

Omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) supplementation in infancy is associated with reduced insulin concentrations and insulin resistance in boys and reduced waist circumference in both sexes at age 5 years, according to a study published online June8 in Pediatrics.

Valene H.L. See, Ph.D., from the Royal Perth Hospital in Australia, and colleagues randomly assigned 420 infants to a daily supplement of n-3 LCPUFA or olive oil (control) from birth to 6 months. Growth, body composition, and cardiometabolic risk factors were evaluated at 5 years of age.

The researchers found that infants who received n-3 LCPUFA had a smaller waist circumference at 5 years (coefficient, 1.1 cm), which remained significant after adjusting for confounders (coefficient, 0.8 cm). Boys who received n-3 LCPUFA supplementation had a 21 percent reduction in insulin concentrations and a 22 percent reduction in insulin resistance versus the control group. At birth, 2.5 years, and 5 years, there were no other differences in growth and cardiometabolic risk factors between the groups.

"Longer-term follow-up of the cohort is warranted to determine whether these differences are maintained into adolescence," write the authors

Topical Rapamycin Effective for TSC-Related Facial Angiofibromas

In continuation of my  update on Rapamycin

Topical rapamycin seems effective for tuberous sclerosis complex (TSC)-related facial angiofibromas, according to a study published online May 23 in JAMA Dermatology.

Mary Kay Koenig, M.D., from The University of Texas Health Science Center at Houston, and colleagues examined the efficacy and safety of topical rapamycin for TSC-related facial angiofibromas in a study involving 179 patients. Participants were randomized in a 1:1:1 ratio to topical formulation containing 1 percent rapamycin, 0.1 percent rapamycin, or vehicle alone (59, 63, and 57 patients, respectively). The formulation was applied daily to designated areas at bedtime.

The researchers observed clinically meaningful and statistically significant improvement in facial angiofibromas for 1 and 0.1 percent rapamycin versus vehicle only, and for 1 versus 0.1 percent rapamycin; most of the improvement was seen in the first month. The Angiofibroma Grading Scale mean improvement at six months was 16.7, 11.0, and 2.1 points for 1 and 0.1 percent rapamycin and vehicle only, respectively (P < 0.001 for 1 and 0.1 percent versus vehicle only). End-of-treatment photos were rated better than baseline for 81.8, 65.5, and 25.5 percent of patients in the 1 and 0.1 percent rapamycin groups and the vehicle group, respectively (P < 0.001 for all three pairwise comparisons).

"Topical rapamycin appears effective and safe for treatment of TSC-related facial angiofibromas," the authors write. "In this trial, the preferred dose was 1 percent once daily."

Several authors disclosed financial ties to Novartis; one author disclosed ties to MedStudy. Several authors have a provisional patent pending

Ref : https://jamanetwork.com/journals/jamadermatology/article-abstract/2682034?resultClick=1

Eating raspberries improves function of cells lining blood vessels, research shows

In continuation of my update on Raspberry

New research led by Dr Ana Rodriguez-Mateos, School of Life Course Sciences, shows that eating red raspberries improves the function of the cells that line blood vessels.

Endothelial cells form the interior lining of our blood and lymphatic vessels. They act as a barrier between the blood or lymph and the surrounding body tissue as well as playing key roles in blood clotting and regulating blood pressure amongst other things. Sometimes these cells stop working efficiently (called endothelial dysfunction) which is thought to be a significant factor in the development of cardiovascular disease.

Dr Rodriguez-Mateos and her colleagues studied ten, healthy male volunteers aged 18-35 years. Participants were randomly given drinks containing no, 200g or 400g of raspberries. Researchers monitored chemicals in their blood and urine as well as their blood pressure and flow-mediated dilation (FMD) of the brachial artery: a measure of how the artery widens when blood flow increases.

The results showed a significant increase in FMD for participants that drank raspberry-containing drinks. The effect lasted for at least 24 hours and there was also a correlating increase in the levels of urolithin metabolites found in their blood. These are produced by bacteria in the gut as ellagitannins, a chemical found in raspberries, are digested. Researchers believe that ellagitannins could therefore be beneficial to vascular health.

If the change in FMD seen could be sustained for long enough, it would reduce a person's risk of developing cardiovascular disease by up to 15%. Further studies are needed to establish whether these results translate into long-term health benefits in the general population and whether red raspberries and other foods rich in ellagitannins (such as strawberries, pomegranate or nuts) should be included as part of a healthy diet to help prevent cardiovascular disease.

Speaking of the findings Dr Rodriguez-Mateos said:

'Although more studies are needed to confirm our findings, we are very excited about the potential role of raspberries and ellagitannins in cardiovascular disease prevention. Following up on this study, we are now investigating the long-term benefits of ellagitannins in a larger group of healthy individuals and we are also looking at how our gut microbiota may have an impact on their health benefits.

More : https://www.kcl.ac.uk/lsm/schools/life-course-sciences/news-events/newsrecords/2018/could-eating-raspberries-prevent-cardiovascular-disease.aspx

Alnylam announces new positive results from Phase 1/2 study of lumasiran in patients with PH1

Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced new positive results from its Phase 1/2 study with lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase (GO) for the treatment of Primary Hyperoxaluria Type 1 (PH1). Results were presented at the OxalEurope, European Hyperoxaluria Consortium, taking place on June 8, 2018 in Naples, Italy.

Updated interim data were from Part B of the Phase 1/2 study and were as of the data cut-off date of March 29, 2018. Part B is a randomized (3:1 drug:placebo), single-blind, placebo-controlled evaluation of lumasiran in patients with PH1. Cohorts 1 and 2 received three monthly doses of lumasiran at 1 mg/kg or 3 mg/kg, respectively; Cohort 3 received two quarterly doses at 3 mg/kg. An additional eight patients received open-label lumasiran in expansions of each of the first two cohorts, totaling 20 patients enrolled. Patients randomized to the placebo group also received subsequent subcutaneous administration of lumasiran following administration of placebo. Patients had a mean age of 14.9 years (range: 6-43) and a mean estimated glomerular filtration rate (eGFR) of 77 mL/min/1.73m2 (range: 42-131).

Lumasiran demonstrated a mean maximal reduction in urinary oxalate of 64 percent in patients enrolled in Cohorts 1-3 (N=12). All lumasiran-treated patients experienced a lowering in urinary oxalate below 0.7 mmol/24 hrs/1.73m2, a threshold level associated with a reduced rate of progression to end-stage renal disease. On day 85, patients receiving lumasiran (N=9) maintained a mean reduction in urinary oxalate of 63 percent (range: 49-73 percent). Alnylam believes the potent and durable reductions in urinary oxalate support a once quarterly, subcutaneous dose regimen. Further, these results continue to support the hypothesis that GO inhibition has the potential to reduce and possibly normalize levels of hepatic oxalate production, thus potentially halting PH1 disease progression. Dosing in Part B of the Phase 1/2 study is ongoing and eligible patients are transitioning into an open-label extension (OLE) study. The Company expects to present additional data from all cohorts as well as from the OLE study in late 2018.

"We are pleased to present data that signal hope to patients with PH1, an ultra-rare, life-threatening disease, with a profound unmet need. Given the encouraging results, we believe that lumasiran has the potential to alleviate the pathologic overproduction of oxalate, the metabolite that causes the severe, systemic manifestations of PH1. Furthermore, we believe these results validate our approach of targeting GO, a key liver enzyme involved in the excessive oxalate output in patients with PH1," said Pritesh J. Gandhi, PharmD., Vice President and General Manager, Lumasiran program at Alnylam. "Based upon our recent discussions with the FDA, we are on track to advance this program into Phase 3 development at mid-year, with the goal of bringing lumasiran to patients around the world as rapidly as possible."

"PH1 is an ultra-orphan disease, with a generally pediatric onset and an immediate need for an effective intervention. Today, patients with advanced disease have no choice but to undergo intensive dialysis and, ultimately, a dual liver/kidney transplant, with no other approved treatment alternatives in place," said Prof. Bernd Hoppe, M.D., Head of the Division of Pediatric Nephrology, Department of Pediatrics, University of Bonn, Germany and an investigator in the lumasiran study. "The data presented on lumasiran provide evidence for oxalate reduction, highlighting the potential of this investigational medicine as an innovative approach for the treatment of patients with PH1."

Lumasiran was generally well tolerated in all patients in the Phase 1/2 study (N=20). Fifteen (75 percent) of patients treated with lumasiran experienced an adverse event (AE); the majority of AEs were mild or moderate in severity and unrelated to study drug. AEs occurring in three or more patients included abdominal pain, headache, nasopharyngitis, pyrexia, and vomiting. Two patients reported injection site reactions, both of which were mild and transient. Two patients reported severe AEs; one patient had pyelonephritis during placebo dosing and one patient had a kidney stone with renal colic after lumasiran dosing. One patient receiving placebo and three patients receiving lumasiran reported serious adverse events (SAEs); none were assessed as related to study drug. The placebo patient experienced kidney stones and pyelonephritis. The lumasiran patients with SAEs included one patient with kidney stones, one patient with fever and abdominal pain, and one patient with gastroenteritis. Lumasiran has not been associated with any clinically significant adverse laboratory findings, and there were no study discontinuations due to AEs through the data cut-off date.

Alnylam recently announced alignment with the U.S. Food and Drug Administration (FDA) on a pivotal study design for lumasiran, including a primary endpoint at six months based on reduction of urinary oxalate, and a study size of approximately 25 patients with PH1. The Company has guided its intention to initiate the Phase 3 trial in mid-2018. Lumasiran has received Breakthrough Therapy Designation from the FDA and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA).

Ref : http://investors.alnylam.com/news-releases/news-release-details/alnylam-reports-updated-positive-results-phase-12-study

Alnylam announces new positive results from Phase 1/2 study of lumasiran in patients with PH1

New approach to kill specific bacteria could be alternative to antibiotics

A new approach to killing C. difficile that silences key bacterial genes while sparing other bacteria may provide a new way to treat the most common hospital-acquired bacterial infection in the United States, according to researchers.

While conventional antibiotics treat bacterial infections, they can also cause a condition in the colon called C. difficile infection, due to the drug killing both good and bad bacteria in the gut.

In a lab, researchers created three new antibiotics that kill C. difficile by preventing the expression of bacterial genes that are important for its survival. This approach -- called antisense therapy -- allows the drug to kill only C. difficile, unlike many antibiotics that kill multiple forms of bacteria.

"We were able to show that these drugs can zero in on and kill C. difficile bacteria while leaving other bacteria alone," said Arun Sharma, associate professor of pharmacology, Penn State College of Medicine. "We're still working to refine these drugs and make them even better, with the eventual goal of testing them clinically."

David Stewart, an associate professor of surgery at the University of Arizona who along with Sharma is a co-principal investigator on this study, said the drug works in a completely different manner than the antibiotics currently used.

"These drugs are organism specific, meaning that they target only one kind of bacteria, kind of like smart antibiotics," Stewart said. "They're precise. And that's especially important with C. difficile infections because this bacteria is uniquely, selectively advantaged to exploit ecological disturbances in the human gut."

While C. difficile is normally present in the gut, other "good" bacteria are also present, and all these bacteria contribute to a person's microbiome. When a person's microbiome is healthy and balanced, it keeps bad bacteria like C. difficile under control.

But if a patient takes an antibiotic for another condition, the antibiotic kills many different types of bacteria, including the good ones keeping C. difficile under control. This allows C. difficile to thrive, causing an infection that can result in severe gastrointestinal symptoms. Since antibiotics can contribute to C. difficile infections, the researchers said a new, alternative treatment for these infections is desirable.

"Ideally, a treatment for C. difficile would have no effect on other bacteria," Stewart said.

The researchers, who recently published their findings in the Journal of Antibiotics, said that while most antibiotics lack organismal specificity -- the ability to target just one type of organism -- antisense treatments show great potential for being able to target only specific bacteria.

"Our antisense antibiotics contain genetic material which is complementary to bacterial genetic material, so we designed our genetic material to target specific genes in C. difficile," Stewart said. "And when our genetic material binds to the bacterial genetic material, it prevents the expression of bacterial genes. And that can cause C. difficile to die."

The drug tested in the study consisted of two components: the antisense compound that targeted the genetic material in C. difficile -- referred to as an antisense oligonucleotide (ASO) -- and a carrier compound that transported the ASO into the bacteria, referred to by the research team as a CAB. The researchers tested three versions of the drug, each with a different version of CAB.

The researchers tested each compound to see how much of the drug was required to kill C. difficile bacteria, whether it was toxic or not to human colon cells, and whether it also harmed other bacteria normally found in the gut -- like E. coli.

"Ultimately, we wanted these compounds to deliver the drug into the C. difficile bacteria without hurting other bacteria or the patient," Sharma said. "After testing these three, we found that one carrier in particular -- CYDE-21 -- was the best at delivering an effective dose of the drug into the bacteria."

 

In the future, the researchers said they will conduct further studies to continue to refine the carriers to increase their capacity and minimize their effect on other bacteria and human cells.

"In this study, as a first effort, the carrier is pretty good, and we'd like to do even better," Stewart said. "It has minimal antibacterial activity, minimal toxicity and it's an effective carrier of our cargo. So what we're working on now is modifying our carriers for future testing in preparation for animal studies."

Ref : https://www.nature.com/articles/s41429-018-0056-9

Two-drug combination provides more reliable, effective care for women suffering miscarriage

In continuation of my update on mifepristone

A combination of the drugs mifepristone and misoprostol can help bring closure to some women and their families suffering from miscarriage, and reduces the need for surgical intervention to complete the painful miscarriage process. Results of a new clinical trial led by researchers at the Perelman School of Medicine at the University of Pennsylvania, show that while the standard drug regimen using misoprostol on its own frequently fails to complete the miscarriage, a combination of misoprostol and the drug mifepristone works much more reliably. The report is published today in the New England Journal of Medicine.

   mifepristone   misoprostol 

Each year in the United States alone approximately 1 million women have miscarriages. When the body does not expel the pregnancy tissue on its own – the final part of a miscarriage – women need to undergo a surgical procedure or take the drug misoprostol. Though often preferable for its convenience and privacy – patients can take it in the comfort of their own homes – misoprostol does not always work, and many women who use misoprostol are still left with no option but to undergo an invasive procedure they wished to avoid, prolonging an already physically and emotionally difficult situation.

"Though rarely discussed openly, miscarriage is the most common complication of pregnancy, and the public health burden is both physical and psychological. For too many women, misoprostol alone just leads to frustration. I have seen my patients suffer from the insult of the treatment failure added to the injury of the initial loss," said study lead author Courtney A. Schreiber, MD, MPH, chief of the division of Family Planning and an associate professor of Obstetrics and Gynecology at the Perelman School of Medicine at the University of Pennsylvania. "As physicians, we have to do better for these patients, and our new study shows that by combining mifepristone with misoprostol, we can."

Mifepristone is used along with misoprostol to induce abortion in early pregnancy. But the effectiveness of mifepristone-misoprostol for miscarriage patients, in comparison to the commonly used misoprostol alone, has been unclear.

In the new study, 300 women who had been diagnosed with early pregnancy loss – described as a miscarriage in the first trimester – were assigned to receive the standard 800 micrograms of misoprostol placed vaginally. Half were also randomly assigned to receive pretreatment with a 200 mg pill of mifepristone, which primes the uterus to respond to misoprostol's contraction-inducing effect.

The researchers found that overall, 91.2 percent of women receiving the mifepristone pretreatment plus misoprostol experienced gestational sac expulsion -; the definition of a completed miscarriage -; 83.8 percent by their first follow-up visit, which occurred two days after the treatment on average. Misoprostol alone was only effective 75.8 percent of the time, with 67.1 percent completing by their first follow up visit.

The researchers looked at a variety of outcomes in the study, and essentially all were better for the women taking mifepristone plus misoprostol. Patients assigned to this group, for example, had a much lower chance (8.8 percent) of needing a surgical intervention by day 30, compared to 23.5 percent for the misoprostol-alone group. There were no significant differences between the groups in terms of pain, bleeding, or other side-effects. Notably, serious side effects were rare in both groups.

Mifepristone is a highly regulated medication. At present, the U.S. Food and Drug Administration requires that the drug be dispensed only in registered hospitals, clinics and doctor's offices, but not in retail pharmacies. Schreiber says that physicians who wish to treat women with miscarriages – including but not limited to physicians in obstetrics, internal medicine, emergency medicine, and family medicine – should consider registration.

"High-quality care for women who suffer miscarriage not only improves physical outcomes, but helps alleviate the psychosocial stress that can accompany the loss of a pregnancy," she says. "Given how common miscarriage is and the effectiveness of the drug combination as shown in this new study, any doctor who cares for women who become pregnant, and therefore could have a miscarriage, should be registered to prescribe and dispense mifepristone."​

Ref : https://www.pennmedicine.org/news/news-releases/2018/june/drug-combination-offers-more-effective-care-for-patients-suffering-miscarriage-penn-study-shows

Sunitinib (Sutent) May Spare Some Kidney Cancer Patients From Organ Removal

In continuation of my update on Sunitinib (Sutent)

Many people with advanced kidney cancer might not need to have their kidneys removed during treatment, something that until now has been standard practice.

Patients who only received a targeted drug for their kidney cancer survived just as well as those who had their cancerous organ removed before drug therapy, according to a new clinical trial.

"We believe this one study will change it so that patients won't get nephrectomies [kidney removal surgery]," said Dr. Bruce Johnson, chief clinical research officer at the Dana-Farber Cancer Institute, in Boston. "If anything, it looks like it's a little bit better if you don't take it out. We think this single study will change what people do."

For about two decades, kidney removal followed by drug therapy has been the standard of care for people with advanced kidney cancer, said Johnson, who is also president of the American Society of Clinical Oncology.

"One of the things that's been odd about kidney cancer is even if you have metastatic disease, where it started in your kidney and spread through your body, there was evidence patients lived longer if you took out their kidney," Johnson said.

Cases where the cancer has spread account for about 20 percent of all kidney cancers worldwide, said study lead researcher Dr. Arnaud Mejean, a urologist with the Georges-Pompidou European Hospital at Paris Descartes University, in France.

But in the intervening years, a number of targeted therapies have been developed that attack the ability of kidney cancer to grow and spread, the researchers added.

Mejean and his colleagues set out to test whether these new targeted drugs are so powerful that they've removed the need for painful, body-wracking kidney removal surgery.

The clinical trial enrolled 450 patients with metastatic kidney cancer, and assigned them to either take the targeted drug sunitinib (Sutent) or have their kidney removed and then take sunitinib.

Sunitinib attacks blood vessel growth that allows cancer to spread throughout the body, and it also blocks other means by which kidney cancer can grow, according to the American Cancer Society.

The patients were followed for about 51 months, and during that time the researchers found that survival was not worse for patients who just took sunitinib.

Overall, survival was 18.4 months without surgery versus 13.9 months with surgery. Similar survival rates also were found in people with an intermediate or poor prognosis.

The two patient groups had a similar rate of tumor shrinkage (just over 27 percent for surgery and 29 percent for sunitinib alone), the findings showed. In addition, average time until cancer progressed was slightly longer for patients who received sunitinib alone compared with those who also had surgery (8.3 months versus 7.2 months).

People who undergo kidney removal must heal before they can start targeted cancer drugs, often losing weeks they don't have to spare, the researchers noted. In some cases, the cancer spreads so quickly during this delay that there's no time to start the drug therapy.

However, the study authors said kidney removal is still the gold standard for people who do not need targeted drug therapy, such as those whose cancer has only spread to one other organ.

Despite these findings, it's not clear that all kidney removal surgeries will end for people with advanced kidney cancer, said Dr. Daniel Cho. He's a medical oncologist at NYU Langone Health's Perlmutter Cancer Center in New York City, and was not involved with the study.

"I don't think it should be across the board a standard of care yet," Cho said.

This approach may work for patients receiving targeted drug therapies, but may not be as effective in patients who are undergoing immunotherapy -- taking drugs to boost their immune system's ability to detect and kill cancer cells, he said.

Some people believe that large kidney tumors actually suppress the immune system and are not very responsive to immunotherapy drugs, Cho said. For the best results in these patients, kidney removal may be necessary.

"There's a certain rationale to remove the primary tumor if you're planning to give immunotherapy," Cho said. "The primary tumor may be creating a more immunosuppressive environment that makes the immune therapy less effective."

On the other hand, "there are those patients who are more likely to have rapidly growing disease, and therefore would more likely benefit from immediate systemic therapy," Cho added. "I really believe we have to be thoughtful about it."

Experimental Drug, Taselisib, Shows 'Modest' Benefit in Slowing Advanced Breast Cancer

A new and highly targeted drug slowed the growth of advanced breast cancers by about an average of two months, researchers report.

"The findings in this study show a modest benefit to a subgroup of women with estrogen receptor-positive tumors," said Dr. Stephanie Bernik, a breast cancer specialist who wasn't involved in the research.

Estrogen receptor-positive tumors are a common subtype of breast cancer that grow in the presence of estrogen. The experimental drug used in the new study, called taselisib, targets a gene called PIK3CA that's tied to cancer growth.

"About 40 percent of all patients with advanced breast cancer estrogen receptor-positive have PIK3CA mutations, which means they could benefit from taselisib," explained study author Dr. Jose Baselga. He's physician-in-chief at Memorial Sloan Kettering Cancer Center in New York City.

"Our findings are proof that targeting this pathway in breast cancer is effective. However, the benefit to patients was more modest than we had hoped for, and there is a risk of considerable side effects with the addition of taselisib," Baselga said in a news release from the American Society of Clinical Oncology (ASCO).

As the researchers explained, taselisib has already proven beneficial for people fighting head-and-neck cancers or certain gynecological tumors. Would it do the same for hormone-sensitive breast cancers?

To find out, Baselga's group worked with 516 women with either locally advanced or metastatic estrogen receptor-positive breast cancers. About two-thirds of the women received taselisib and a standard chemotherapy drug, fulvestrant, while the remaining third received fulvestrant and a placebo.

Women on the drug combo regimen had 30 percent lower odds of their cancer worsening, compared with those who got standard chemo alone, the study found. Women who got taselisib typically went an average of 7.4 months without signs that their cancer was worsening, compared to 5.4 months without the drug -- a two-month difference.

Tumor shrinkage was much more evident in women taking taselisib (28 percent of patients) versus those on fulvestrant alone (12 percent), the findings showed.

However, there was a downside: While 17 percent of women taking taselisib had to quit their treatment because of side effects, that was true for just 2 percent of those who weren't taking the medicine, the investigators found.

Still, Bernik said the study offers breast cancer patients some hope.

"Although tumor growth was only suppressed by two months, this medication opens the door to further investigation with drugs that target cancers with the PIK3CA gene mutation," she said.

"One would hope that because we know targeting this gene decreases tumor growth, perhaps combining it with various other drugs might make it more effective, and also direct research to developing other drugs that work in a similar fashion," Bernik reasoned.

Dr. Alice Police directs breast surgery at Northwell Health Cancer Institute in Sleepy Hollow, N.Y. She called targeted therapies like taselisib "a wonderful new field that looks for medications that keep cancer cells from growing while protecting normal tissue."

Still, "this drug was a little disappointing to the researchers in that its benefit was not as great as they had hoped, and the drug was more toxic than they had hoped," Police said.

The findings were scheduled for presentation on Saturday at ASCO's annual meeting, in Chicago. Because the new study was presented at a medical meeting, its findings should be considered preliminary until published in a peer-reviewed journal.

Ortho Dermatologics Receives FDA Approval for Altreno (tretinoin 0.05%) Lotion For Acne

Ortho Dermatologics, one of the largest prescription dermatology health care businesses in the world and a division of Bausch Health Companies Inc.  announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Altreno (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Altreno is the first formulation of tretinoin in a lotion, and has been shown to be effective and generally well-tolerated. Altreno is expected to be available during the fourth quarter of 2018.

FDA approval of Altreno builds upon our strong acne portfolio, providing physicians and patients a trusted retinoid in a lotion formulated to enhance the user's experience with the inclusion of moisturizing attributes of hyaluronic acid, glycerin and collagen," said Bill Humphries, president, Ortho Dermatologics. "Altreno lotion spreads easily and is quickly absorbed into the skin allowing acne patients to easily incorporate this once-daily treatment into their skin care regimen."

Extensive clinical data has shown that retinoids are highly effective in treating acne and are considered a cornerstone of topical therapy. However, a common perceived barrier to their use is that treatment with retinoids is associated with skin irritation, such as dryness and peeling, and sensitivity. In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients.1,2

"Topical retinoids are a foundational treatment for all patients with acne, but they often cause skin irritation," said Joshua Zeichner, M.D., director, Cosmetic and Clinical Research in Dermatology, The Mount Sinai Hospital, New York City. "With the efficacy expected from a retinoid, plus a proven tolerability profile, Altreno will be an ideal choice for many of my patients."

Ref : https://www.drugs.com/history/altreno.html