Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer

In continuation of my update on olaparib

AstraZeneca and Merck & Co., Inc., (Merck: known as MSD outside the US and Canada)  announced that the US Food and Drug Administration (FDA) has approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy. Patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer are selected for therapy based on an FDA-approved companion diagnostic for Lynparza.

This is the first regulatory approval for a PARP inhibitor in the 1st-line maintenance setting for BRCAm advanced ovarian cancer. The approval was based on positive results from the pivotal Phase III SOLO-1 trial  in which Lynparza reduced the risk of disease progression or death by 70% in patients with BRCAm advanced ovarian cancer who were in complete or partial response to platinum-based chemotherapy (HR 0.30 [95% CI 0.23-0.41], p<0.0001) compared to placebo.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit, AstraZeneca, said: “Women with ovarian cancer are often first diagnosed with advanced disease, which is associated with poor outcomes. In SOLO-1, Lynparza in the first-line maintenance setting reduced the risk of disease progression or death by 70 percent for patients with BRCAm advanced ovarian cancer. Today’s approval is a critical advancement and brings us closer to our goal of helping these patients achieve long-term remission.”

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, Merck Research Laboratories, said: “The expanded approval of Lynparza based upon the SOLO-1 trial has the potential to change medical practice and reinforces the importance of knowing a woman’s BRCA status at diagnosis. We continue to work in collaboration with AstraZeneca on our overall goal of improving outcomes for patients.”

In the SOLO-1 trial, with median 41 months of follow-up, the median progression-free survival (PFS) for patients treated with Lynparza (n=260) was not reached compared to 13.8 months for patients treated with placebo (n=131). In the trial, 60% of patients receiving Lynparza remained progression-free at 3 years compared to 27% of patients receiving placebo. The data from the SOLO-1 trial can be found in the October 21, 2018, online issue of the New England Journal of Medicine.

The most common adverse reactions (ARs) in ≥10% of patients taking Lynparza in the SOLO-1 trial were nausea (77%), fatigue (67%), abdominal pain (45%), vomiting (40%), anemia (38%), diarrhea (37%), constipation (28%), upper respiratory tract infection/influenza/nasopharyngitis/bronchitis (28%), dysgeusia (26%), dizziness (20%), decreased appetite (20%), neutropenia (17%), dyspepsia (17%), dyspnea (15%), leukopenia (13%), UTI (13%), thrombocytopenia (11%) and stomatitis (11%). The most common Grade ≥3 ARs were anemia (21%) and neutropenia (6%). Dose interruptions due to an AR of any grade occurred in 52% of patients receiving Lynparza and 17% of those receiving placebo. Seventy-two percent (n=186) of patients on Lynparza remained on the recommended starting dose of 300 mg (two 150 mg tablets twice daily) versus 97% (n=126) on placebo. Adverse reactions that most frequently led to discontinuation in patients treated with Lynparza were fatigue (3.1%), anemia (2.3%), and nausea (2.3%). Eighty-eight percent (n=230) of patients on Lynparza continued treatment without an AR-related discontinuation versus 98% (n=127) on placebo.

Kathleen Moore, Co-Principal Investigator of the SOLO-1 trial and Associate Director for Clinical Research, Stephenson Cancer Center at The University of Oklahoma, Oklahoma City, Oklahoma, said: “SOLO-1 is truly a landmark trial in gynecologic cancer. This approval will likely change the way we treat women with BRCA-mutated advanced ovarian cancer. The ability to offer this important first-line maintenance treatment option to eligible patients may slow down or even stop the natural course of disease progression.”

AstraZeneca and Merck are exploring additional trials in ovarian cancer, including the ongoing GINECO/ENGOTov25 Phase III trial, PAOLA-1. This trial is testing the effect of Lynparza in combination with bevacizumab as a maintenance treatment for patients with newly-diagnosed advanced ovarian cancer, regardless of their BRCA status. Results are expected during the second half of 2019.

--------------------------------------------------------------------------------------------------------------------------

Lynparza (olaparib) Approved by US FDA for First-Line Maintenance Therapy in BRCA-Mutated Advanced Ovarian Cancer

Nabriva Therapeutics Announces Acceptance of the New Drug Application for Intravenous Contepo to Treat Complicated Urinary Tract Infections by FDA

Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) and granted a priority review for Contepo™ (fosfomycin for injection) to treat complicated urinary tract infections (cUTIs), including acute pyelonephritis. The acceptance of the NDA indicates that the FDA has deemed the application sufficiently complete to allow a substantive review. The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review of the Contepo NDA is June 30, 2019. In addition to priority review, Contepo has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the FDA for the treatment of several serious infections, including cUTI.

“The acceptance of the Contepo NDA marks another major milestone for Nabriva Therapeutics, demonstrating our commitment to bring novel anti-infective agents that address the urgent, unmet medical need in patients with serious infections,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “Contepo, if approved in the United States, represents a first-in-class intravenous antibiotic with broad spectrum activity against Gram-negative and Gram-positive organisms, including ESBL-producing Enterobacteriaceae and other contemporary multi-drug resistant (MDR) organisms.”

The NDA submission is utilizing the 505(b)(2) regulatory pathway and is supported by a robust data package, including a pivotal Phase 2/3 clinical trial (known as ZEUS™), which met its primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.

In the NDA acceptance letter, the FDA stated that no filing or potential review issues were identified. In addition, the Agency stated that it has not referred Contepo to an advisory committee meeting at this time.

Ref: https://www.rxlist.com/monurol-drug.htm#indications

Experimental drug can protect against Ebola in a single dose

Dr. Thomas Geisbert, a world-renowned Ebola researcher at The University of Texas Medical Branch, said that previous therapeutics typically were of the "one bug, one drug" variety. But because of the unpredictable nature and variety of the Ebola virus, scientists have been seeking a way to protect against different strains of the virus.

Our experimental drug can protect against all forms of Ebola known to harm people, suggesting that it will continue to protect people if the Ebola viruses evolve over time," said Geisbert, who is a professor of microbiology and immunology at UTMB.

The team of scientists demonstrated that a two-antibody cocktail called MBP134 could fully protect nonhuman primates and ferrets against lethal Ebola virus infections of caused by the Bundibugyo and Sudan strain as well as the deadliest Zaire strain that caused the 2013-16 epidemic in West Africa and the current outbreak in the Democratic Republic of Congo.

"We were able to protect the nonhuman primates against all the Ebola species plaguing people at a single low dose," said Larry Zeitlin, president of Mapp Biopharmaceutical Inc. "Further studies exploring even lower doses could open the door to treatment via auto-injectors like the kind used for allergic reactions. The ability to quickly and efficiently provide protection against all Ebola viruses in a single dose would reduce the burden on health care workers in the field during outbreaks, especially in regions that have a less-developed infrastructure."

Ref: https://www.cell.com/cell-host-microbe/fulltext/S1931-3128(18)30632-2

FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections

In continuation of my update on Itraconazole

Mayne Pharma Group Limited (ASX: MYX) announced,  that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole) 65mg capsules. Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients.

Tolsura is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy). These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.

Mayne Pharma's CEO, Mr Scott Richards said, "We are very pleased to have received FDA approval of this patented formulation of itraconazole which incorporates Mayne Pharma's proprietary SUBA technology to improve the bioavailability of poorly soluble drugs. Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes. We are proud to offer a new treatment option for patients with these life-threatening infections. We believe physicians will appreciate having access to Tolsura, which has been shown in clinical studies to have increased bioavailability and significantly reduced variability when compared to conventional oral itraconazole capsules."

"After many years of research and development and working closely with key global opinion leaders in infectious disease management, Tolsura represents a major milestone in the SUBA (SUper-BioAvailable) drug delivery platform at Mayne Pharma."

The Company will directly commercialise Tolsura and plans to launch in January 2019 with a new institutional sales team focused primarily on hospital-based infectious disease specialists. Tolsura has four granted patents from the United States Patent and Trademark Office with expiry dates ranging from 2023 to 2033.

The US anti-fungal triazole market has a current value of US$600m according to IQVIA and based on the clear unmet clinical need in serious systemic infections, the addressable market is estimated at US$200m[1].

Mayne Pharma directly markets more than 60 products in the US including three patent protected dermatology products Fabior® (tazarotene) foam, Sorilux® (calcipotriene) foam and Doryx® MPC (doxycycline) delayed-release tablets. The Company recently acquired Lexette® (halobetasol) foam used to treat plaque psoriasis which it expects to also launch in January 2019. 

---------------------------------------------------------------------------------------------------------------------------

FDA Approves Tolsura (SUBA®-itraconazole capsules) for the Treatment of Certain Fungal Infections

FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome

The U.S. Food and Drug Administration,  approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects the connection between nerves and muscles and causes weakness and other symptoms in affected patients. This is the first FDA approval of a treatment for LEMS.

“There has been a long-standing need for a treatment for this rare disorder,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “Patients with LEMS have significant weakness and fatigue that can often cause great difficulties with daily activites.”

In people with LEMS, the body’s own immune system attacks the neuromuscular junction (the connection between nerves and muscles) and disrupts the ability of nerve cells to send signals to muscle cells. LEMS may be associated with other autoimmune diseases, but more commonly occurs in patients with cancer such as small cell lung cancer, where its onset precedes or coincides with the diagnosis of cancer. The prevalence of LEMS is estimated to be three per million individuals worldwide.

The efficacy of Firdapse was studied in two clinical trials that together included 64 adult patients who received Firdapse or placebo. The studies measured the Quantitative Myasthenia Gravis score (a 13-item physician-rated categorical scale assessing muscle weakness) and the Subject Global Impression (a seven-point scale on which patients rated their overall impression of the effects of the study treatment on their physical well-being). For both measures, the patients receiving Firdapse experienced a greater benefit than those on placebo. 

The most common side effects experienced by patients in the clinical trials were burning or prickling sensation (paresthesia), upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension and muscle spasms. Seizures have been observed in patients without a history of seizures. Patients should inform their health care provider immediately if they have signs of hypersensitivity reactions such as rash, hives, itching, fever, swelling or trouble breathing.

The FDA granted this application Priority Review and Breakthrough Therapy designations. Firdapse also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

FDA Approves Firdapse (amifampridine) for Lambert-Eaton Myasthenic Syndrome

--------------------------------------------------------------------------------------------------------------

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery

In continuation of my update on Dexamethasone

Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that the U.S. Food and Drug Administration (FDA) has approved Dextenza (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery.

“We are extremely pleased to announce the approval of Dextenza, coming so soon after our pre-approval inspection and approximately one month ahead of the PDUFA date,” said Antony Mattessich, the Company’s President and Chief Executive Officer. “Just over a year ago, we set out to augment our scientific and formulation expertise with individuals who have the skills and experience to create a first-class team to get Dextenza approved and become a commercial stage biopharmaceutical company. We believe this approval is a major external validation of the drug delivery technology platform, and also of the transformation that has taken place at Ocular. While we are excited by the approval of our first drug product, our goal has always been to bring Dextenza to as many patients as possible in the near term and to revolutionize ophthalmic drug delivery by making drops obsolete. We now turn our efforts towards the successful commercial launch of Dextenza.”

Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. The approval of Dextenza was based on (i) demonstrated efficacy in two randomized, vehicle-controlled Phase 3 studies in which a statistically significantly higher incidence of subjects were pain free at day 8 post-cataract surgery compared to the vehicle control group and (ii) safety in the two Phase 3 studies as well as a third randomized, vehicle-controlled Phase 2 study. The Company believes the delivery profile represents a differentiated and potentially transformational new product for patients and physicians. For patients, Dextenza offers the convenience of a full course of post-surgical steroid treatment with a physician’s one-time placement of a single intracanalicular insert. Dextenza has the potential to replace a complex eye drop regimen that under the current standard of care requires up to 70 topical ocular steroid drops.

“Compliance with taking eye drops after eye surgery is very challenging for patients and a concern for surgeons,” said Michael Goldstein, MD, Chief Medical Officer. “The approval of Dextenza offers surgeons the opportunity to treat patients with a preservative-free steroid after surgery with the placement of a single drug insert. With this product, patients may be liberated from having to deal with the burdensome regimen of using steroid eye drops after ophthalmic surgery.”

In connection with the commercial launch of Dextenza, Ocular Therapeutix also submitted an application for transitional pass-through payment status after receiving FDA approval and intends to submit an application for a J-code ahead of the January 2019 deadline.

-----------------------------------------------------------------------------------------------------------------------

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery

FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns

  In  continuation of my update on   glycerol phenyl butyrate   

        Horizon Pharma plc (NASDAQ: HZNP) announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for Ravicti (glycerol phenylbutyrate) Oral Liquid to include infants younger than two months of age living with a urea cycle disorder (UCD).

Ravicti is now FDA-approved for use as a nitrogen-binding agent for chronic management of UCDs in adults and children of all ages who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. Ravicti must be used with dietary protein restriction and, in some cases, dietary supplements. Ravicti is not indicated for treatment of acute hyperammonemia in patients with UCDs, and its safety and efficacy for the treatment of n-acetylglutamate synthase (NAGS) deficiency has not been established.

“The FDA approval of Ravicti for children younger than two months provides a new alternative for the management of patients with a UCD that is easy to dose and administer to infants given the liquid formulation,” said Nicola Longo, M.D., Ph.D., clinical geneticist at Primary Children’s Hospital and the University of Utah Hospital, and a lead investigator of a clinical study evaluating Ravicti for newborns. “UCDs are severe and can be life-threatening. We hope that the combination of early diagnosis – through newborn screening or by measurement of ammonia levels – and the availability of novel treatments, such as this one, can help to improve the outcome of affected patients.”

A study was conducted to assess safety, efficacy and pharmacokinetics in pediatric patients with UCDs two months of age and younger (n=16). In the study, 10 patients transitioned to Ravicti from sodium phenylbutyrate, three transitioned from intravenous sodium benzoate and sodium phenylacetate, and three were treatment naïve. Patients were treated with Ravicti for an average of 10.7 months. Results demonstrated safety and efficacy in children younger than two months, with Ravicti-treated patients maintaining stable ammonia levels relative to their pre-study enrollment. In addition, mean ammonia levels were lower during treatment with Ravicti compared to baseline values.

“As we increase our efforts to develop new investigational medicines for people living with rare and rheumatic diseases, Horizon continues to seek ways to better serve patients with our current medicines,” said Elizabeth Thompson, Ph.D., vice president, clinical development, rare diseases, Horizon Pharma. “The FDA approval of Ravicti for children under the age of two months is a milestone in our efforts to help people living with UCDs, and we are proud to be bringing a new treatment option to the vulnerable newborn patient population.”

A UCD is a rare genetic disorder that affects approximately 1 in 35,000 live births in the United States. It is caused by an enzyme deficiency in the urea cycle, a process that is responsible for converting excess ammonia from the bloodstream and ultimately removing it from the body. Because of this, people with a UCD experience hyperammonemia, or elevated ammonia levels in their blood, that can then reach the brain and cause irreversible brain damage, coma or death. UCD symptoms may first occur at any age depending on the severity of the disorder, with more severe defects presenting earlier in life. 

--------------------------------------------------------------------------------------------------------------------------

Horizon Pharma plc Announces FDA Approval to Expand the Age Range for Ravicti (glycerol phenylbutyrate) Oral Liquid to Include Newborns

FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors

In continuation of my update on albuterol

Teva Pharmaceutical Industries Ltd., announced  that the U.S. Food and Drug Administration (FDA) has approved ProAir ® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, the first and only digital inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir ® Digihaler™ is indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older.

“This approval marks a significant milestone not only for Teva, but for the respiratory community as it allows patients and their caregivers to better understand inhaler usage through digital technology,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Teva recognizes the importance of integrating technology into patient care, and we are very proud to lead the way with the approval of ProAir ® Digihaler™. The digital technology built into ProAir ® Digihaler™ provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD management.”

ProAir ® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow. This inhaler-use data is then sent to the companion mobile app using Bluetooth ® Wireless Technology so patients can review their data over time, and if desired, share it with their healthcare professionals.

“There are 25 million Americans living with asthma1, many of whom use inhalers as part of their treatment regimen. Despite advancements in care over the years, we know that many are using their rescue medications incorrectly2 or too often3,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “The FDA approval of ProAir ® Digihaler ™ is significant because it may help patients track their inhaler usage and provide data that can be used to work more closely with their HCPs on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations.”

The approval of ProAir ® Digihaler™ is based on the review of a supplemental new drug application (sNDA) submitted by Teva to the FDA. ProAir ® Digihaler™ combines a breath-activated, multi-dose dry powder inhaler with albuterol, the most widely used asthma rescue medication, with a built-in electronic module and a companion mobile app.

“One of the challenges physicians are faced with in caring for their asthma and COPD patients is knowing if their patients are using their inhaled medication as they should. That’s what makes a product like this so important to doctor-patient discussions,” said Tushar Shah, M.D., Global Head of Specialty Clinical Development & Medical Affairs at Teva Pharmaceuticals. “Offering a tool that enables doctors to see data on their patients’ inhaler usage will allow them to have more productive conversations about identifying issues and how to manage their illness.”

---------------------------------------------------------------------------------------------------------------------

FDA Approves ProAir Digihaler (albuterol sulfate) as the First and Only Digital Inhaler with Built-In Sensors

FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease

In continuation of my update on Levodopa

Acorda Therapeutics, Inc. today announced that the U.S. Food and Drug Administration approved Inbrija™ for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa. OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.

“Today’s approval of Inbrija marks a major milestone for both Acorda and the Parkinson’s community, for whom we are gratified to have developed this much needed therapy,” said Ron Cohen, M.D., Acorda President and CEO. “This milestone resulted from over two decades of research and development, beginning in the laboratory of Dr. Robert Langer at Massachusetts Institute of Technology, through years of enormous perseverance and ingenuity by the entire Acorda team.”

“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” said Todd Sherer, Ph.D., CEO, The Michael J. Fox Foundation. “The Foundation provided funding for the early clinical development of Inbrija because patients told us that OFF periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control.”

“In the clinical study program, Inbrija established its safety profile and demonstrated clinically meaningful improvements in motor function, as measured by the UPDRS Part III,” said Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida. “Inbrija helps address a significant unmet need for people with Parkinson’s, and we look forward to adding this new treatment option to our armamentarium.”

FDA approval of Inbrija was based on a clinical program that included approximately 900 people with Parkinson’s on a carbidopa/levodopa regimen experiencing OFF periods. Inbrija is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks.

“I’m delighted that Inbrija has been approved and may be added to patients’ existing Parkinson’s medications for on-demand use, based on individual patient need,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We thank the FDA for a constructive dialogue throughout the development program and their partnership during the review cycle. We especially thank all those who volunteered for the Inbrija clinical trials, without whose commitment new medications could not be developed. And we are grateful for the people living with Parkinson’s, their care partners, researchers, clinicians and advocacy groups, who have all collaborated with us to help achieve this milestone.”

------------------------------------------------------------------------------------------------------------------------



FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease

Naloxone Nasal Spray Works Best to Stop Opioid OD...

In continuation of my update on naloxone

A one-step nasal spray is the easiest form of naloxone to give someone suffering an opioid overdose, researchers say.

Increased public availability of naloxone, also known by the brand name Narcan, is considered a key way to reduce opioid overdose deaths. But there's more than one way to administer it, and it wasn't clear which method would be most successful when given by a bystander.

In this study, 138 adults watched a two-minute video demonstrating how to administer naloxone using one of the three methods -- two nasal sprays and one intramuscular shot. Each participant then selected one method to administer naloxone to a mannequin.

The study participants had a higher rate of success with the single-step nasal spray than with an intramuscular naloxone injection. They administered the one-step nasal spray faster than either a multi-step atomized spray or shot.

"With training, nasal sprays in general had a higher degree of success than the shot," said study author William Eggleston. He's a clinical assistant professor in the School of Pharmacy and Pharmaceutical Sciences at Binghamton University in New York.

"Even if it seemed to us it was a no-brainer that we should be using nasal sprays, we had no data before, so now we have some to support that," he said in a university news release.

https://en.wikipedia.org/wiki/Naloxone#/media/File:Naloxone.svg