West Coast Editor
Gearing up to offer Phase III data with three drug candidates, Pain Therapeutics Inc. kicked off the late-stage trial of its third compound - Remoxy, a longer-acting version of the narcotic oxycodone formulated in a way to prevent recreational abuse or accidental overdose.
The South San Francisco-based company's stock (NASDAQ:PTIE) closed Thursday at $7.44, up 1 cent.
The Phase III study is a randomized, double-blinded, placebo-controlled test designed to confirm efficacy and safety in patients with chronic pain, and PTI plans to enroll about 200 subjects with moderate to severe osteoarthritic pain in more than 20 centers. After a one-week titration period, patients will get Remoxy or placebo for at least four weeks, with dosing at 20 mg twice daily. The primary endpoint is analgesic efficacy.
Sold under the trade names Tylox, Percodan and Oxycontin, oxycodone can be abused orally or by crushing the tablets for sniffing or dissolving in water to inject for a morphine-like high. Because of the way PTI's version of oral Remoxy is formulated, crushing or otherwise physically manipulating it does not defeat the long-acting mechanism, the company said.
Remoxy even resists more sophisticated methods of extraction, such as using acids or alcohol, since most of its active ingredient is "trapped" by the high-viscosity capsule, the company said.
PTI also noted it has met all major predicted milestones for 2004, with two other compounds also in Phase III trials: Oxytrex for chronic, severe low back pain, and PTI-901 for irritable bowel syndrome. The target market for the trio of drug candidates exceeds $3 billion per year, the company said.