Pfizer's pain med clears PhIII as long-delayed Remoxy waits in the wings

Pfizer ($PFE) posted some promising top-line results for its Phase III pain drug ALO-02, an abuse-resistant formulation of oxycodone that sounds quite a bit like Remoxy, the long-delayed treatment codeveloped with Pain Therapeutics ($PTIE). Pfizer isn't pulling the plug on Remoxy, committing to the drug through a bevy of setbacks, but the progress of its in-house candidate could eventually spur a shift in strategy.

In a 12-week Phase III trial on patients with moderate-to-severe chronic lower back pain, ALO-02 met its primary efficacy endpoint of significantly lowering daily self-reported pain ratings compared to placebo, the company said. The drug's most common side effects were nausea, vomiting and diarrhea, Pfizer said, and the company plans to unveil ALO-02's full results at an upcoming medical conference.

Pfizer's drug is designed to deter abuse by encasing its extended-release oxycodone payload in pellets of naltrexone, which counteracts the opioid agonist. When the capsule is taken as directed, the naltrexone remains harmlessly sequestered, but if the pellets are crushed and snorted, the second ingredient kicks in and strips away the drug's effect.

Meanwhile, Remoxy, an extended-release oxycodone with an abuse-discouraging technology all its own, has endured two FDA rejections in its years of development. But Pfizer affirmed its confidence in the drug in October, saying it plans to follow through on the additional studies needed to sway the agency and expecting another decision in mid-2015.

ALO-02's latest results suggest it may be ready for the FDA before then, but Pfizer isn't getting into specifics about its long-term plans for either drug, saying in a statement today that it's "developing a range of treatments because no one therapy is appropriate for all patients suffering from pain. Some of these treatments include extended-release opioids with technology designed to help deter abuse and misuse."

Despite its years of up-and-down results, Remoxy apparently still holds promise in the eyes of Pfizer's R&D decisionmakers, who spared the drug from a far-reaching round of cuts last year. Pfizer picked up rights to the drug through its $3.9 billion buyout of King Pharmaceuticals in 2011.

- read the statement