Shares of Pain Therapeutics (NASDAQ: PTIE) are taking a steep tumble after its CEO Remi Barbier said the clinical-stage drug company faced great odds in filing an “administrative appeal” with the Federal Drug Administration after US regulators rejected its opioid pain relief drug.
Indeed, Barbier unsettled investors by saying the appeal is unlikely to help to reverse the status of Remoxy, its oxycodone capsules for pain management. “I don’t believe an administrative appeal is going to resolve the status of Remoxy,” Barbier said on an investor call.
In response to Barbier’s comments, investors sent Pain Therapeutics shares down 59.6% to $1.17.
Last August, the FDA rejected Remoxy in a complete response letter, arguing that the benefits of the drug failed to outweigh its risks.
Separately, the Austin, Texas-based company also announced that it is being awarded a $3.5 million research grant from the National Institute of Health that will support a Phase 2 program for PTI-125, its drug to treat Alzheimer’s disease.
The NIH grant will pave the way for the company to conduct clinical tests of PTI-125 in patients with Alzheimer’s disease.
Pain Therapeutics is set to introduce its first Phase 2 study using PTI-125 in the fourth quarter and a second Phase 2 study next year.
The company is also developing a simple blood test, called PTI-125DX, to detect whether a person has Alzheimer’s disease, years before symptoms appear.
Contact Ellen Kelleher at [email protected]