Compounds to treat chronic pain represent a multibillion-dollar market opportunity for drugmakers, as innovative new pain drugs make certain specialty pharmaceutical companies bucketloads of cash. Will King Pharmaceuticals
Remoxy is Pain, King, and drug-delivery specialist DURECT's
On Tuesday, the FDA not only accepted the application, but also gave Remoxy a Priority Review designation, trimming its standard 10-month review period to a mere six months. Many other compounds have faced arbitrary FDA review delays this year. But save for Amgen's
The FDA gives Priority Review designation to compounds that may "provide a significant improvement compared to (already) marketed products." According to an older look at FDA drug approvals from Booz Allen Hamilton, priority-review-designated drugs have historically enjoyed a 62% success rate of regulatory approval on their first go-around, compared to 34% for drugs that receive a standard review.
During its second-quarter earnings conference call, King thought it "likely" that the FDA would request an advisory panel hearing prior to Remoxy's December PDUFA date. While such hearings are never 100% predictors of how the agency will rule, one could give us a better idea of where Remoxy stands in the FDA's eyes.
Meanwhile, rival Alpharma
Both of these compounds trail OxyContin developer Purdue Pharma's own abuse-deterrent version of OxyContin, but Purdue's got long odds of gaining marketing approval first, following an unfavorable FDA panel hearing in May. Whatever happens, the abuse-deterrent drug war should only intensify in the coming months.