When will this laxative finally poop out?

Adolor's regulatory roller-coaster ride was extended, yet again with a new FDA action date of May 10, 2008. A few years ago, really thought they would wipe out the competition after finally submitting an NDA for Entereg® (alvimopan) for the treatment of post-operative ileus (POI), a condition known to extend hospital stays and, therefor, costs after abdominal surgery. Despite having received fast-track status from the FDA, the drug's development since acquisition by Adolor has been anything but fast (or even moderately efficient). The development program was besieged by delays, primarily in subject recruitment and study completion, which were exacerbated by the fact they pretty much had mixed efficacy results in the multitude of phase III studies. The delays and announcement of negative study results in late 2002/early 2003 even lead to investors filing suit claiming the company had mislead them about the drug in public statements.

Nevertheless, Adolor plodded through and finally submitted a New Drug Application (NDA) for the POI indication to the FDA in 2004. In July 2005 the shit started hitting the fan. The data on the primary end-point was weak (to say the least), so Adolor had to conduct some more studies. While the company did receive an approvable letter, safety concerns came to light based on data from clinical trials of the drug's use in opioid bowel dysfunction (OBD; constipation caused by use of opiates). These issues have continued to dog the company through every round of review. Last month, the FDA advisory panel recommended approval of the drug (which has been co-developed with GSK) for the POI indication. The endorsement from Robert Levine, a Professor of Gastroenterology at SUNY, Syracuse was, underwhelming [emphasis added]

I think for the patient's sake I would agree that the benefits marginally overcome the negative [Reuters]

During the time Adolor (and investors) has focused on Entereg, the company has had 3 other failed compounds (two kappa agonists developed by Adolor R & D failed in phase II, & a sterile lidocaine patch in-licensed from Epicept, which very expectedly flamed out in Phase III development). In the past year, the Adolor's only saving grace was actually the advancement of two delta agonists from the research lab into clinical research that has now provide the company with a much needed cash influx courtesy of a new deal with Pfizer.

Adolor in-licensed the product from Roberts in 1999 (Roberts had previously in-licensed it from Lilly) and I'm pretty sure the patent for use in POI expires in 2011. With today's announcement of further delays for Entereg, the question remains why even bother at this point?

Tags: health care; FDA; Adolor; GSK; Entereg/alvimopan; POI; constipation; pharmaceuticals; Health; medicine

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