Lightlake Therapeutics 開發解癮藥

On-Label Nasal Naloxone in the Works Pharmaceutical company/NIDA seeking FDA approval for naloxone nasal spray by Kristina FioreStaff Writer, MedPage Today 06.13.2015 An official formulation of nasal naloxone for reversing opioid overdoses that doesn't have to be used off-label may be on the market soon. Lightlake Therapeutics has opened a rolling submission of the NDA for its nasal naloxone to the FDA, according to a release from the National Institute on Drug Abuse (NIDA), which is partnering with the company to develop the drug. Naloxone is technically only available as an injection, made by Hospira, and in auto-injector form known as Evzio by Kaleo Pharma. Amphastar sells the lone nasal formulation -- the concentration of the drug is higher than that of injectable naloxone since it's not administered into or near the blood stream -- but it is technically for off-label use. It will be beneficial to have an on-label nasal naloxone formulation on the market, said Andrew Kolodny, MD, chief medical officer of Phoenix House. "Doctors will be much more easily able to prescribe it, and insurance companies will be able to pay for it," Kolodny told MedPage Today. But advocacy groups warned that having on-label nasal naloxone will only be helpful if it's not too expensive for municipalities or other community distribution programs to afford. "If it costs under a dollar, it will be great news for distribution programs," said Eliza Wheeler, project manager for the DOPE program at Harm Reduction Coalition. "If it costs more than that, which it will, it changes nothing for us, most likely." Wheeler's group felt the squeeze last November when Amphastar more than doubled the price of its nasal naloxone formulation, from about $13 to $30 per cartridge. Caleb Banta-Green, PhD, who specializes in the epidemiology of drug abuse at the University of Washington in Seattle, noted that even the rescue kits that use the "cheap" formulation of the drug -- the intra-muscular version -- cost about $30 each right now. "This is absurd, since this is a very inexpensive [generic] pharmaceutical product, there's no reason an easy-to-use kit should cost more than a few dollars," Banta-Green told MedPage Today. "The financial incentives in the U.S. are entirely responsible for the expense." He added that cost concerns are essential, as the nasal product should be in the hands of every chronic opioid user. The Lightlake/NIDA product could provide improvement over the current off-label delivery of nasal naloxone by having all of the components in one place. Currently, the naloxone cartridges have to be purchased separately from the atomizers that enable nasal delivery, and it's more of a "do-it-yourself" solution. An actual nasal spray could be simpler to use, but Kolodny noted that it's not clear if a spray could offer better outcomes than intramuscular injections of the drug. Those issues may be discussed at an upcoming FDA meeting on nasal naloxone, held July 1 and 2 at its White Oak Campus in Silver Spring, Md.