A promising new drug for treating Obesity known as Contrave® developed by Orexigen Therapuetics, appears to have moved into the final states of FDA review, clearing the way for probable approval.
The drug was previously rejected by the FDA who in February 2011 stated that a large scale study of cardiovascular (CV) risk would be needed before they could consider approval. It now appears that guidelines for the study have been clarified and agreed upon in high level meetings between the FDA and Orexigen.
The FDA stated that:
"if the interim analysis meets the specified criteria to exclude an unacceptable increased CV risk, the drug could be approved."
"While we still plan to convene a public advisory committee meeting to discuss topics related to obesity drug development early next year, that meeting will not impact on the advice provided...."
Contrave® is a combination of naltrexone HCl and bupropion HCl that was studied for treatment of obese people with a benchmark of losing and maintaining a 5% weight loss.
The FDA said that it requires a trial focused on the "intent to treat" that should include parameters for assessing interim and final results. Similar types of evaluations are used for trials of diabetes drugs. The FDA also specified that the trial should include obese people with a CV risk of between 1 and 1.5 percent.
Michael Narachi, President and CEO of Orexigen gave positive feedback:
"We have been working with clinical experts, advocacy groups, and our partner, Takeda, throughout this process and are pleased with the feedback provided by FDA that identified a very clear and feasible path forward for this important therapy."
What the new feedback from the FDA does, is create a clear and achievable path for implementing the final clinical trial giving Orexigen a protocol for the trials. It enables them to proceed as soon as they are able and opens business opportunities for them to begin engaging International partners.
Ken Fujioka, MD, director of the Nutrition and Metabolic Research Center and The Center for Weight Management at the Scripps Clinic, and investigator for the Contrave Obesity Research Program states that :
"In my experience, Contrave demonstrated great potential for the treatment of obesity in a broad range of patients ..... On behalf of those working hard to address this significant unmet need, I am pleased to see that a pragmatic approach to bringing this therapy to market appears to be taking shape."
Orexigen hosted a conference call yesterday, the webcast of it can be accessed on (866) 730-5763 (domestic) or +1 (857) 350-1587 (international), participant code 66064656. The webcast can be accessed on the investor relations part of the Orexigen web site at http://www.orexigen.com/ and will be available for two weeks.
Written by Rupert Shepherd BSc.