Nano cap Pain Therapeutics (NASDAQ:PTIE) jumps 65% premarket on increased volume in response to its announcement that it has received feedback from the FDA regarding the additional studies needed to refile its New Drug Application (NDA) seeking approval of abuse-deterrent REMOXY ER (extended-release oxycodone capsules CII).
The company says it will need to conduct two additional studies, a clinical abuse potential study assessing the intranasal route of abuse and a non-clinical abuse potential study using household solvents. It believes it can complete both by year-end at a cost of $3 - 4M.
Afterward, it plans to conduct a pre-NDA meeting with the agency and then resubmit its NDA under Priority Review via the 505(b)(2) pathway.
In September 2016, the company received a CRL in response to its marketing application, the third such rejection.
Management will host a conference call this morning at 8:00 am ET to discuss the developments.
Previously: FDA rejects Pain Therapeutics' Remoxy ER marketing application; shares plummet 67% premarket (Sept. 26, 2016)