Amphastar announces the receipt of a CRL for intranasal naloxone for the emergency treatment of opioid overdose.
Amphastar Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for Naloxone Hydrochloride 2mg/0.5mL nasal spray (intranasal naloxone), indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
The CRL identifies issues including user human factors study, device evaluation, and other items that need to be addressed before the NDA can be approved.
“While we are disappointed to have not received approval at this time, we intend to continue to work with the FDA to address their concerns in the CRL and hope to bring Intranasal Naloxone to the market as soon as possible,” Dr. Jack Zhang, Amphastar’s CEO, said.
Deaths from prescription opioids have more than quadrupled since 1999. From 2000 to 2015 more than half a million people died from drug overdoses. 91 Americans die every day from an opioid overdose.
Amphastar said it will continue to offer naloxone in pre-filled syringes while the company pursues the NDA for intranasal naloxone.
Amphastar is a specialty pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable and inhalation products. In 2014, the company also commenced sales of insulin active pharmaceutical ingredient products.
Most of the company’s finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. www.amphastar.com.
(Source: Globe Newswire)