An FDA panel has recommended that the agency approve Orexigen Therapeutics? and Takeda?s obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.
An FDA panel has recommended that the agency approve Orexigen Therapeutics’ and Takeda’s obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.
Back in October, FDA rejected lorcaserin (Arena Pharmaceuticals) and Qnexa (Vivus) due to safety concerns.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13 to 7 that the available data adequately demonstrated that the potential benefits of Contrave outweigh the potential risks when used long term in a population of overweight and obese individuals and support approval. The Committee also voted 11 to 8 that a dedicated study to examine the drug’s effect on risk for major adverse cardiac events should be conducted as a post-approval requirement.
A Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 has been assigned for the review of the new drug application.
“Not surprisingly... safety seems to be the major concern, as it is for all potential new agents. In clinical trials, naltrexone/bupropion was associated with heart risks, hypertension and heart rate increases, dizziness, renal dysfunction, seizures and psychiatric disturbances, such as suicidal behavior,” said Formulary Editorial Advisor Michele B. Kaufman, PharmD, clinical pharmacist, New York Downtown Hospital, NYC, and president, PRN Communications Inc.
“Perhaps part of the reason for recommending this agent’s approval was due to the fact that both naltrexone and bupropion are already FDA-approved as monotherapy agents, for other indications. I believe that older, already approved anorexigenics would not be able to withstand the safety rigor in the current FDA-approval process. Additionally, new chemical entities are under much greater scrutiny due to lessons learned with past agents; therefore very few of these agents will likely be approved.”
Michael Narachi, president and CEO of Orexigen, said in a company press release that the company is encouraged by the panel's view of the risk-benefit profile of Contrave. “We look forward to continued discussions with the FDA regarding the design of a post-marketing study to evaluate cardiovascular risk and to address the questions raised at the meeting today in preparation for our PDUFA action date in January,” Narachi said.
“It is well known that obesity is associated with increasing lifetime risks of type 2 diabetes, hypertension, heart disease, stroke, and major cancers-including prostate, colon, and breast cancer. It is also associated with severe and chronic depression as well as osteoarthritis,” said Naomi Neufeld, MD, FACE, clinical professor of pediatrics, Geffen School of Medicine, UCLA, Los Angeles, and CEO and founder of Kidshape, a family-based pediatric weight management program.