For the second time in as many weeks, an aspiring maker of diet pills has cut its workforce in response to a rejection by the FDA. This time, Orexigen Therapeutics has dismissed roughly 40 percent of its staff, or 23 employees. Not huge numbers in the scheme of things, but certainly symbolic of the difficulty a trio of small companies is having as they attempt to win over a safety-conscious FDA.
"We continue to believe in the potential of Contrave (its diet drug) and look forward to discussions with the FDA," Orexigen ceo Mike Narachi says in a statement. "Unfortunately, given the near-term uncertainty of Contrave approval, we felt it prudent to consolidate and focus our resources. We are deeply grateful for the dedication and tremendous effort provided by all of our colleagues who are impacted by this realignment."
Of course, a ceo is, by nature and by mandate, going to put a positive spin on such situations, but there really is no near-term uncertainty. Orexigen is going to spend a good bit of time and money trying to satisfy the FDA, which wants the drugmaker to conduct a randomized, double-blind, placebo-controlled trial in order to gauge cardiovascular risks (read this).
As one Wall Street analysted noted recently, Orexigen faces a "cloudy future" if the drugmaker can not convince the FDA to wait for results until after approval, especially since Takeda Pharmaceuticals, which struck a marketing deal with Orexigen, does not contribute to pre-approval cardiovascular study costs (back story).
The requirement was noted when the FDA issued Orexigen a complete response letter, less than two months after an FDA advisory panel recommended the pill for approval, but also voted in favor of requiring additional studies to assess cardiovascular risks. The rejection marked the third consecutive time in recent months that a new diet drug has been rejected over some type of side effect issue. The others are Lorqess from Arena Pharmaeuticals (see here) and Qnexa from Vivus.
None of this is particularly surprising, though, given that each pill demonstrated reason for concern and the agency worries that diet drugs will not be used or prescribed appropriately. After all, who can forget the pill mills that popped up during the fen-phen years?
pic thx to alan cleaver on flickr
1 Comment
It's good to see that the FDA is actually doing their job. If the drug company didn't do the appropriate research, it's totally understandable why it was denied. What is sad though is that the company had to downsize in order to keep doing business, however, if they had released the drug and it caused side-effects, who knows how many people would have been affected/injured due to the drug. How many drugs out there have caused issues already due to side-effects not noted prior to FDA approval.