Pain Therapeutics Inc. (PTIE) fell 26 percent after the company said manufacturing issues for a painkiller developed with Pfizer Inc. (PFE) may delay regulatory approval by a year or “significantly longer.”
Pain Therapeutics dropped $1.37 to $3.93 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The shares tumbled 43 percent on June 24 after the Austin, Texas-based developer disclosed the delay of the painkiller, called Remoxy.
The Food and Drug Administration postponed clearance of the medicine, designed to curb drug abuse, after finding inconsistent results during laboratory tests of batches of the medicine, Pain Therapeutics said today in a statement. The inconsistencies may be the result of a manufacturing deficiency or a flaw in the testing method, the company said.
“Sufficient information does not yet exist to accurately assess the time required to resolve the concerns raised” by the FDA, Pain Therapeutics said. “Potential regulatory approval of Remoxy in the U.S. is unlikely to occur in less than one year, and could be delayed significantly longer.”
New York-based Pfizer said last month that it was working on a “manufacturing issue” in the new drug application for Remoxy. Pfizer, the world’s biggest drugmaker, last week won approval for another tamper-resistant painkiller called Oxecta. Pfizer partners on Oxecta with Acura Pharmaceuticals Inc. (ACUR), based in Palatine, Illinois.
With the Acura drug approved, Pfizer might decide it’s not worthwhile to continue to develop Remoxy, Les Funtleyder, a portfolio manager with Miller Tabak & Co. in New York, said on June 24.
Acura declined 8 cents, or 2 percent, to $4.20 after gaining 9.9 percent on June 24.
Remoxy is a long-acting oxycodone pill with a taffy-like texture that prevents the medicine from being crushed, snorted or dissolved in alcohol for a quick high. The drug was one of the experimental pain products Pfizer gained in its $3.3 billion acquisition of King Pharmaceuticals in March.
Pain Therapeutics and Cupertino, California-based Durect Corp. (DRRX) helped develop the therapy and would get royalties on sales if the drug is approved. Durect fell 19 cents, or 8.9 percent, to $1.94 after dropping 31 percent on June 24.
Remoxy was delayed in 2008 when the FDA asked for more lab data. The companies resubmitted the drug application at the end of last year. The FDA has also been working with all makers of long-acting pain pills on a new doctor training and education program to minimize the risk of abuse and overdose.
Pfizer also has a morphine pill designed to deter abuse called Embeda that has been off the market since March because of manufacturing issues.
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