UPDATE: Pain Therapeutics shares slide 20% as company charges FDA with basic math errors
Shares of Pain Therapeutics Inc. fell 20% in premarket trade Tuesday, after the company accused the Food and Drug Administration of making basic math errors and other mistakes in a meeting to discuss its Remoxy abuse-deterrent gel formulation of the painkiller oxycodone. In an unusually critical statement, the company said it is no closer to product approval today than it was more than a year ago. "REMOXY remains an odyssey without a homecoming," Chief Executive Remi Barbier said in the statement. "We had hoped for a fair, neutral and impartial review of the REMOXY data. Instead, we walked out of this meeting feeling a bit disoriented by FDA's lack of transparency, clarity or helpfulness. It's a rare occasion when two parties can't agree on simple math. We can't work with shambolic regulations. This is not how you win support for innovation." Remoxy is Pain Therapeutics' lead pipeline candidate that has already gone through a Phase III trial that met its primary endpoint of statistical significance. But the company said its abuse-deterrent properties are subject to a difference of opinion, with the FDA insisting as long as the drug can be extracted, even if it requires equipment and a lot of time, it is a risk for patients. "We are unable to follow the logic by which a drug product should never release drug," said Barbier. "More generally, as the regulatory requirements for REMOXY have changed frequently and suddenly over time, we have experienced significant delays and have incurred unanticipated expenses related to the overall REMOXY development program." Pain Therapeutics' shares have fallen 80% in the last 12 months, while the S&P 500 has gained 2.9%. Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.