King's all kid gloves on Embeda launch
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.”