Orexigen Therapeutics ($OREX) is hoping to succeed where competitors Arena and Vivus have failed. On Tuesday the drugmaker will face an expert panel to review its application for obesity drug Contrave, a combination of the antidepressant bupropion and an addiction treatment called naltrexone. In its most recent clinical trial, the drug helped obese patients lose 8.1 percent of their weight--17 pounds--in little over a year. Nausea was experienced by one-third of patients on the treatment. The biggest hurdle the drugmaker faces is safety; cardio and psych side effects could spook the FDA, which has come down hard on safety issues related to obesity drugs.
But as the third drugmaker to submit an obesity drug app this year, Orexigen has had a chance to see the questions its competitors have faced, and may be better prepared to respond. "We have paid close attention to these regulatory interactions and have been applying any learnings to our own regulatory review in preparation for our advisory committee review in December," Orexigen CEO Michael Narachi noted in a conference call, as quoted by Bloomberg. "The recent advisory committee meetings highlighted the importance of clearly articulating risk-mitigation plans." And since Orexigen's Contrave uses two well-established drugs, it has more long-term safety data to fall back on that Arena or Vivus.
In FDA panel briefing documents released this morning, staffers noted that Contrave met only one of two recommended effectiveness measures, and was linked to cases of "high blood pressure, psychiatric side effects, dizziness and kidney dysfunction," according to Bloomberg. The FDA will issue its final decision on January 31st.
- here are the panel briefing documents
- see the Bloomberg article on Orexigen
- check out the Seeking Alpha report