Alpharma's strong results with its extended-release, abuse-deterrent morphine backed the company's statements that the FDA-pending Embeda 's Phase III data merit marketing clearance.

The news probably did little to take the pain away from rejected suitor King, and upped interest by other would-be buyers in the space.

In a Sept. 9 poster session at the American Academy of Pain Management in Nashville, Alpharma said Embeda capsules - which consist of morphine with sequestered naltrexone, an opioid antagonist - provided significant relief in patients with moderate to severe pain due to osteoarthritis of the hip or knee, compared to placebo.

Those taking Embeda reported significantly more effective pain relief, as measured by mean change in the weekly Brief Pain Inventory (BPI) Average Pain Intensity Score from baseline to the 12-week endpoint of the study, with 72.5 percent getting relief of at least 30 percent from baseline, compared to 57.8 percent given placebo.

The 344-patient trial included a screening and washout period from previous treatments (less than or equal to 14 days), after which patients got two periods of treatment with study drugs.

Patients were first titrated to effective pain management levels with Embeda during open label titration. Then, they were randomized to double-blind treatment with either Embeda or placebo for the 12-week period. They were allowed to use acetaminophen as a rescue medication, up to 500 mg every six hours, as needed.

Findings showed Embeda was safe and well-tolerated, too.

The news reduced fretting that may have remained over the chances for Embeda's new drug application, accepted for priority review Sept. 2.

"Even studies of powerful narcotics with well-established efficacy could fail to achieve statistical significance if the study is not designed appropriately," wrote Leerink Swann analyst Gary Nachman in a July 18 research report.

Painful registration pathways for analgesics

Examples of hard development roads for pain drugs are easy enough to find, and include Endo's ketoprofen patch (and, earlier, its Opana ER ), as well as Posidur , from Durect (¹ Also see "Endo Ketoprofen Patch Fails Two Phase III Studies; Firm Revises 2007 Guidance" - Pink Sheet, 13 July, 2007.).

Acetavance , the intravenous acetaminophen from Cadence, also ran into trouble, achieving mixed results in Phase III trials (² Also see "Cadence Plans FDA Meeting To Discuss Mixed Trial Results For IV Acetaminophen" - Pink Sheet, 11 January, 2008.).

Nor has Embeda's path been entirely smooth. Alpharma withdrew from FDA its first try for the product because of technical issues, and resubmitted the NDA at the end of June (³ Also see "Alpharma Withdraws Embeda NDA" - Pink Sheet, 22 April, 2008.).

In August, King offered $1.4 billion for Alpharma but was turned down, although the latter vowed to entertain "bona fide" offers from any party that properly valued the firm (⁴ Also see "King Makes Play For Alpharma To Build Specialty Pain Franchise" - Pink Sheet, 22 August, 2008.).

King's $33-per-share cash offer - a 49 percent premium - put Alpharma up for consideration by various would-be buyers, and Leerink's Nachman wrote in an Aug. 25 research report that he "wouldn't be surprised if a final price tag reaches the high $30s."

- Randall Osborne (r.osborne@elsevier.com)

Alpharma Ups Ante With Phase III Embeda Proof

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