Adapt Pharma earns FDA approval for opiod overdose intranasal spray

Adapt Pharma's Narcan nasal spray became the first noninjectable treatment for opioid overdose emergencies thanks to its FDA approval on Nov. 19.

Narcan requires no assembly or priming prior to use, Adapt says in a release. The delivery device administers a 4-mg dose of naloxone in one nasal spray of 0.1 ml of solution. The medication is sprayed into a nostril while the patient is lying on his or her back.

FDA granted the medicine its fast-track designation and priority review, as the death toll from opioid overdose mounts (it was 24,500 in 2013) and public pressure to fix the problem grows, with some going as far as to call for the resignation of former Commissioner Dr. Margaret Hamburg after the agency approved Zohydro, an opioid with significant abuse potential.

"We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication--a critical attribute for this emergency life-saving drug," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, in a statement.

In addition, the NIH's National Institute on Drug Abuse helped facilitate the approval by designing and conducting clinical trials to test the intranasal formulation's effectiveness.

Besides drug delivery, sister publication FiercePharma points out that Narcan is differentiating itself from Amphastar Pharmaceuticals' ($AMPH) incumbent injectable on pricing thanks to an alliance with the Clinton Foundation to establish a so-called Public Interest Price approach.

The foundation has a goal of preventing 10,000 prescription drug-related deaths over 5 years, and earlier this year helped kaléo sell its Evzio Auto-Injector to universities and other institutional buyers at the federal price of less than $30 instead of the wholesale price of $575 for two units of the naloxone delivery device. The handheld, single-use Evzio gives users voice and visual instructions describing how to inject the overdose patient.

Meanwhile, others are scrambling to catch up to Ireland's Adapt Pharma in the emergency opioid abuse treatment market. Amphastar is developing an intranasal formulation of its own, while the U.K.'s Reckitt Benckiser is partnering with Lexington, KY, nasal spray developer AntiOp and has the option to acquire all rights to the product upon FDA approval.

Whether in emergency treatment, recovery or deterrence, drug delivery innovations are central to combating the opioid (and heroin) abuse epidemic, which has been implicated in the unprecedented rise of the death rate among middle-aged white Americans without a college degree.

In an online survey of physicians conducted on behalf of FierceDrugDelivery by Quantia MD, 31% of physicians said formulations containing opioid antagonists are the most needed form of deterrence. But there are no opioids on the market with effective antagonists, or substances that interfere with the euphoria associated with drug abuse. Most approved or in-development opioid abuse deterrent formulations use physical or chemical barriers to discourage manipulation, such as snorting or crushing.

And in the drug abuse treatment and recovery space, the FDA just granted Braeburn Pharmaceuticals and Camurus fast-track designation for their weekly and monthly subcutaneous injectables of buprenorphine to treat addiction. Along with partner Titan Pharmaceuticals ($TTNP), Braeburn is awaiting word from the FDA for its subdermal implant that delivers the antagonist buprenorphine as a maintenance treatment for opioid addiction. Finally, BioDelivery Sciences ($BDSI) sells transmucosally delivered Bunavail to treat drug addiction. The drug is delivered via the inner cheek. It also contains buprenorphine and naloxone.

- here's FiercePharma's take
- get the FDA's statement
- read the release