FDA Grants Competitive Generic Therapy (CGT) Designation to Purdue Pharma’s Investigational Nalmefene HCl Injection for the Emergency Treatment of Known or Suspected Opioid Overdose
Committed to advancing solutions to the opioid addiction crisis, Purdue will not profit from nalmefene HCl.
STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. today announced that the U.S. Food & Drug Administration (FDA)’s Office of Generic Drugs has granted Competitive Generic Therapy (CGT) designation to nalmefene hydrochloride (HCl) injection, the company’s investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose. This news follows the FDA’s recent Fast Track designation for nalmefene HCl, which was announced last month.1
The FDA’s CGT designation allows for expedited review of generic versions of medications with inadequate generic competition, and is intended to help facilitate the timely market entry of generic drugs.2 The Fast Track and CGT designations are timely, as overdose deaths due to opioids continue to rise, driven by abuse of extremely potent and long-lasting synthetic opioid agonists, particularly illicitly manufactured fentanyl and its analogues.3
“Purdue recognizes the immediate and critical need to treat potential fatal overdoses associated with opioid abuse and addiction,” said Craig Landau, MD, president and CEO, Purdue Pharma. “We are encouraged by FDA’s recent regulatory designations for nalmefene HCI, as we believe they acknowledge the urgent need for new and potentially more effective medications to address this public health emergency. Our company is committed to making this potentially life-saving treatment available as broadly and quickly as possible. As committed previously, if approved by FDA, Purdue and its subsidiaries will not profit from any future sales of nalmefene HCl injection.”
Nalmefene HCl has a longer duration of action than naloxone, another opioid antagonist currently approved for emergency treatment of known or suspected opioid overdose.4 If approved, the duration of effect of nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose. There is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete development or gain FDA approval.
“We are pleased the FDA has granted nalmefene HCl injection CGT designation, a decision that supports our common interest in making this important treatment option available as broadly and quickly as possible,” said Richard Fanelli, PhD, vice president, Regulatory Affairs, Imbrium Therapeutics L.P., a wholly-owned subsidiary of Purdue. “We are committed to working with the agency’s generic products division to provide an injectable generic version of nalmefene HCl.”
For additional information about Purdue’s commitment to addressing the opioid crisis, please read our open letter.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety.
Purdue established Imbrium Therapeutics L.P. to further advance its emerging portfolio and develop its pipeline in the areas of CNS, non-opioid pain medicines, and select oncology through internal research, strategic collaborations and partnerships. Purdue’s subsidiaries also include Adlon Therapeutics L.P., focused on treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) and related disorders, and Greenfield Bioventures, an investment vehicle focused on value-inflection in early stages of clinical development. For more information, visit www.purduepharma.com.
1 Purdue Pharma L.P. FDA grants Purdue Pharma’s nalmefene HCl injection Fast Track designation for the emergency treatment of known or suspected opioid overdose. Mar 13, 2019. Accessed Apr 18, 2019. Retrieved from https://www.purduepharma.com/news-media/2019/03/fda-grants-purdue-pharmas-nalmefene-hcl-injection-fast-track-designation-for-theemergency-treatment-of-known-or-suspected-opioid-overdose/.
2 U.S. Food & Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition. Feb 15, 2019. Accessed Apr 18, 2019. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631456.htm.
3 Centers for Disease Control and Prevention. Opioid Overdose: Understanding the Epidemic. Accessed Apr 19, 2019. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/.
4 National Institutes of Health. Drug Record: Nalmefene. Updated Oct 2018. Accessed Apr 19, 2019. Retrieved from https://livertox.nih.gov/Nalmefene.htm.
Purdue Pharma L.P.