Biotech Stocks Facing FDA Decision In August

Pain Therapeutics
Pain Therapeutics

The FDA’s final word on Pain Therapeutics Inc.’s (PTIE) investigational pain drug Remoxy ER is slated for August 7, 2018.

Remoxy ER is a long-acting abuse-resistant version of oxycodone, a powerful narcotic painkiller, formulated with Durect Corp.’s (DRRX) ORADUR technology.

Remoxy is bioequivalent to Purdue Pharma’s Oxycontin, meaning the two drugs provide similar levels of oxycodone in people when used as intended.

Last year, Oxycontin brought home sales of $1.94 billion, according to Symphony Health Solutions.

In June an FDA panel had voted 14 to 3 against the approval of Remoxy ER. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

The New Drug Application for Remoxy has been rejected thrice by the FDA – i.e., in December 2008, June 2011, and September 2016.

Is it going to be a déjà vu for Remoxy ER or will it make it to the finish line at least this year?

PTIE closed Wednesday’s (Jul 25) trading at $2.17, down 2.25%.