Showing posts sorted by relevance for query Budesonide. Sort by date Show all posts
Showing posts sorted by relevance for query Budesonide. Sort by date Show all posts

Thursday, June 15, 2017

Combination drug therapy safe, effective in treating asthma patients

In continuation of my update formoterol and  budesonide

A post-marketing safety study mandated by the U.S. Food and Drug Administration has shown that a combination drug therapy for the treatment of asthma is safe and effective.

The therapy tested consisted of a long-acting beta agonist, formoterol, added to an inhaled glucocorticoid, budesonide.



"Our study showed no significant increase in serious adverse events in the combination therapy," said Stephen Peters, M.D., Ph.D., professor of pulmonary, critical care, allergy and immunologic diseases at Wake Forest Baptist Medical Center and lead author of the study.

"A large number of studies have shown that this type of combination therapy really helps asthma control and decreases symptoms. Our findings, in combination with results from another FDA-mandated safety study, are very reassuring to those of us who treat asthmatic patients."

The study is published in the Sept. 1 issue of the New England Journal of Medicine.

In this multicenter, double-blind, 26-week study, the scientists evaluated whether the addition of formoterol to budesonide maintenance therapy increased the risk of serious asthma-related events in patients with moderate to severe asthma. Study participants were age 12 or older, had persistent asthma, received daily asthma medication and had one to four exacerbations in the previous year.



Of the 11,693 patients enrolled in the study, an asthma-related event occurred in 43 patients who received the combination therapy of budesonide and formoterol and in 40 patients who received only budesonide. Two asthma-related deaths were reported in the combination arm of the study and none in the single-therapy group, which is not statistically significant.

In addition, a secondary finding showed a 16.5 percent decrease in asthma exacerbations in the combination therapy group as compared to the group receiving budesonide.

Overall, the researchers found that treatment with budesonide-formoterol was associated with a lower risk of asthma exacerbations than budesonide and a similar risk of serious asthma-related events.

Wednesday, September 21, 2011

Santarus, Inc. recently  announced that analysis of top-line safety data from a double blind, multicenter 12-month extended use study in patients treated daily with either the investigational drug budesonide (see structure) MMX® 6 mg or placebo will be provided as support for the company's planned submission of a New Drug Application (NDA) for budesonide MMX 9 mg to the U.S. Food and Drug Administration (FDA) for the induction of remission of mild or moderate active ulcerative colitis. Santarus had previously announced results from two Phase III clinical studies that evaluated the safety and efficacy of budesonide MMX 9 mg over an eight week course of treatment for induction of remission of mild or moderate active ulcerative colitis.

Highlights (of the study of 123 patients) are: 
  • The frequency of treatment related adverse events for budesonide MMX 6 mg (21.0%) was similar to placebo (21.3%).
  • Mean morning plasma Cortisol levels remained within normal limits at all visits for both budesonide MMX 6 mg and placebo.
  • There were no clinically meaningful differences in the numbers of patients with abnormal bone mineral density scans at baseline and end-of-study between budesonide MMX 6 mg and placebo. 
"Now that we have the top-line safety data from the extended use study, we are moving forward as planned to submit the NDA in December 2011 for budesonide MMX 9 mg for the induction of remission of mild to moderate active ulcerative colitis," said Gerald T. Proehl, CEO/President of the company...
More.: http://ir.santarus.com/releasedetail.cfm?ReleaseID=606515

Wednesday, October 22, 2014

FDA Approves Uceris (budesonide) Rectal Foam for Ulcerative Colitis

In continuation of my update on budesonide

Salix Pharmaceuticals, Ltd. announced that the Food and Drug Administration (FDA) has granted final approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis (UC) extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies which are often ineffective due to insufficient distribution of active drug to the distal colon. On September 15, 2014 the FDA tentatively approved Uceris rectal foam pending expiration of the 45-day waiting period described in section 505( c )(3)( C ) of the Federal Food, Drug and Cosmetic Act. The waiting period has expired and the FDA has granted Uceris rectal foam final approval as of October 7, 2014.

Tuesday, April 16, 2013

Santarus Receives FDA Approval of Uceris (budesonide) for the Induction of Remission in Patients with Active, Mild to Moderate Ulcerative Colitis

In continuation of my update on Budesonide

We know that, Budesonide is a glucocorticoid steroid for the treatment of asthma and non-infectious rhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. In addition, it is used for Crohn's disease (inflammatory bowel disease).

It is marketed by AstraZeneca as a nasal inhalant under the brand name Rhinocort (in Denmark, as Rhinosol), as an oral inhalant under the brand name Pulmicort (in Israel, Budicort), and as either an enema or a modified-release oral capsule under the brand name Entocort. It is also sold in combination with formoterol (Oxis) in a single inhaler, under the brand name Symbicort. In Brazil it is marketed by Eurofarma under the brand name NoexEntocort EC is an oral capsule marketed in the United States by Prometheus Laboratories.

Tuesday, June 30, 2015

Pharmalink AB acquires anti-inflammatory drug candidate from Synartro AB

Pharmalink AB, a specialty pharma company, announces that it has acquired a novel product candidate in development for treating inflammation from Synartro AB. No financial details are disclosed.

The product candidate, which consists of an anti-inflammatory drug conjugated to a biopolymer, has been developed using Synartro's drug delivery technology to create locally acting pharmaceuticals with limited systemic exposure. Pharmalink intends to develop the product for osteoarthritis, an indication where it has demonstrated promising results in pre-clinical studies. Pharmalink will apply its formulation and clinical development expertise to advance the candidate product through clinical trials towards market.
 Budesonide.png

Pharmalink has extensive experience in developing locally delivered anti-inflammatory drugs with limited systemic uptake. Its most advanced product is Nefecon®, (a new oral formulation of the glucocorticosteroid, budesonide above structures respectively), modified-release capsule of the corticosteroid, budesonide, in Phase 2b clinical development for treating patients with IgA nephropathy at risk of developing end-stage renal disease, despite optimized standard-of-care therapy.

Friday, June 26, 2015

Pharmalink AB acquires anti-inflammatory drug candidate from Synartro AB

Pharmalink AB, a specialty pharma company, announces that it has acquired a novel product candidate in development for treating inflammation from Synartro AB. No financial details are disclosed.
The product candidate, which consists of an anti-inflammatory drug conjugated to a biopolymer, has been developed using Synartro's drug delivery technology to create locally acting pharmaceuticals with limited systemic exposure. Pharmalink intends to develop the product for osteoarthritis, an indication where it has demonstrated promising results in pre-clinical studies. Pharmalink will apply its formulation and clinical development expertise to advance the candidate product through clinical trials towards market.
 Budesonide.png

Pharmalink has extensive experience in developing locally delivered anti-inflammatory drugs with limited systemic uptake. Its most advanced product is Nefecon®, (a new oral formulation of the glucocorticosteroid, budesonide above structures respectively), modified-release capsule of the corticosteroid, budesonide, in Phase 2b clinical development for treating patients with IgA nephropathy at risk of developing end-stage renal disease, despite optimized standard-of-care therapy.