NASDAQ has halted trading of CombinatoRx's stock today as an FDA advisory committee holds a public meeting to discuss the NDA for Exalgo, a pain drug developed by Neuromed Pharmaceuticals. CombinatoRx and Neuromed signed a merger agreement in June which is expected to close in the fourth quarter of this year. Covidien bought U.S. rights to the drug from Neuromed in June.
Exalgo is being evaluated for the management moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time. The benefit of Exalgo is that sufferers won't have to take the drug as often as other treatments already on the markets. But FDA staff reviewers have already expressed concern about the drug's potential for abuse, noting that it can easily be crushed. Today an outside panel of experts will weigh in on Exalgo's safety compared to other forms of the drug. A final decision on the NDA is expected in November.
- check out CombinatoRx's release
- here's a Reuter's report