King's all kid gloves on Embeda launch

Share this article:
King's all kid gloves on Embeda launch
King's all kid gloves on Embeda launch
King's launch of Embeda, a pain drug containing morphine, demonstrates that even supposedly abuse-resistant narcotic products need to take a careful approach in their marketing.

Embeda is an extended-release analgesic combining morphine sulfate with naltrexone, a substance designed to reduce morphine's effect. Tamper with it, and the naltrexone is released, but the formulation has not been shown to confer abuse resistance.

Following an FDA warning letter in October for a video news release, the firm is taking extra care. Professional ads launched in November feature a five-page ad running in primary care titles, four-and-a-half of those pages devoted to risk info.

Without sampling or traditional advertising allowed, launch expenditures are also going into educational materials use by sales reps, speaker-training meetings and speaker programs to educate the marketplace about Embeda and its REMS program.

“We're using an annotated package insert to work with doctors,” Jack Howarth, King's VP, investor relations told MM&M. “Communications are strictly controlled by FDA and DDMAC. We're being very careful to work with them on everything we do.”

This launch “will be heavily channeled through medical education and direct sales-force involvement, because…there are limitations in how you can promote opioids,” King CEO Brian Markison said back in August, prior to FDA's warning.

The FDA had said the VNR omitted risks—including that patients could die from chewing, crushing or dissolving the pill—and made misleading claims.

Embeda netted $11 million in third-quarter sales, and King has filed two other abuse-deterrent opioids—Acurox and Remoxy—with FDA.

King's “leadership in abuse-deterrent opioids is underappreciated,” wrote Collins Stewart analyst Louise Chen in a recent note. “We estimate that [these products] could be a multi-billion dollar opportunity at branded drug prices.”
Share this article:

Email Newsletters

More in News

Sales of Biogen MS pill pick up overseas

Sales of Biogen MS pill pick up overseas

Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.

GSK second-quarter sales disappoint

GSK second-quarter sales disappoint

Executives urge analysts to focus on the company's long-term potential.

House bill would speed approval once EU OKs same product

House bill would speed approval once EU OKs ...

The Speeding Access to Already Approved Pharmaceuticals Act of 2014 would require FDA to expedite the review of pharmaceuticals that are already approved by the European Union