Chew On This: FDA OK's King's Tamper-Resistant Morphine, Embeda

Embeda to launch in September backed by 610 sales reps, Chief Commercial Officer Andrzejewski says.

King Pharmaceuticals' tamper-resistant pain drug Embeda scored FDA approval Aug. 13, positioning it to be the first marketed long-acting opioid designed to cut back on misuse.

Embeda (morphine sulfate and naltrexone hydrochloride) extended-release is an oral drug indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The Schedule II drug is intended for once- or twice-daily dosing.

Steve Andrzejewski, the company's chief commercial officer, said in an interview that Embeda will hit the market in September, backed by Embeda's pain and specialty drugs sales force. King gained Embeda through its earlier acquisition of Alpharma, valued at $1.6 billion (Also see "King’s Dogged Pursuit of Alpharma Comes Up Aces" - Pink Sheet, 24 Nov, 2008.).

Though the approval is a major win for King, opioids have long been a culprit of misuse and abuse, and the drug maker admits: "there is no evidence that the naltrexone in Embeda reduces abuse liability of Embeda." In a study of recreational drug users, Embeda was shown to have reduced drug liking and euphoria compared with an equivalent dose of immediate-release morphine sulfate solution. But King said it's not known whether the addition of naltrexone will prevent the drug's abuse.

At the start of June, FDA delayed action on Embeda and other opioids to further evaluate their tamper-proof claims and understand how such drugs work. The agency said a class-wide requirement for a risk evaluation and mitigation strategy was not the cause of such hold-up (Also see "Opioids Pending At FDA Held Up By Anti-Abuse Claims, Not REMS Planning" - Pink Sheet, 8 Jun, 2009.). Embeda's recent approval suggests that in the case of this particular drug the agency appears to be satisfied with its review.

In a same-day FDA call, the agency said Embeda's REMS is similar to that for Purdue's OxyContin , offering a number of vehicles for risk communication, Andrzejewski noted.

The Embeda capsules contain extended-release morphine pellets, each with an inner core of naltrexone hydrochloride - an opioid receptor antagonist -designed to reduce drug liking and euphoria when tampered with. If Embeda is crushed or chewed, the naltrexone is released and absorbed with the morphine, reversing the morphine's subjective and analgesic effects.

Embeda is not intended for use as a PRN (take as needed) analgesic and also is not indicated for postoperative use.

King gears up for nearing launch

King expects to start shipping the drug in September with plans to up its commercial spend in the second half of the year to account for launch programs, execs told investors during an Aug. 6 earnings call (Also see "Business And Finance In Brief" - Pink Sheet, 10 Aug, 2009.). Pricing information for Embdea won't be released until closer to the expected launch date.

"The first thing we need to do is get our advertising materials - journal or other educational materials that our sales people use - cleared through [FDA's] Division of Drug Marketing, Advertising and Communications," Andrzejewski said.

More than 600 sales reps will promote the drug - 450 specialty drug reps and 160 pain reps - to various physicians who treat pain. King is planning to do some speaker programs as part of its educational efforts, as well.

About 50 million people in the U.S. live with chronic pain, King estimates.

In addition to Embeda, King has two other abuse-resistant pain products in late-stage development - a long-acting oxycodone Remoxy and a short-acting oxycodone Acurox . The drug maker expects to meet with FDA by end of this quarter to discuss an earlier "complete response" letter it received for Acurox, Andrzejewski noted.

-Carlene Olsen ([email protected])