STAMFORD, Conn.--(BUSINESS WIRE)--Purdue Pharma L.P. today announced the initiation and first participant enrollment in a Phase 1 clinical study that will examine pharmacokinetic properties of nalmefene hydrochloride (HCl). This milestone comes at a time when deaths resulting from synthetic opioid overdose are at record highs,1 and follows the U.S. Food and Drug Administration (FDA)’s recent Competitive Generic Therapy (CGT) and Fast Track designations for Purdue’s nalmefene HCl injection for the emergency treatment of known or suspected opioid overdose, which were announced earlier this year.2,3
The NAL1002 study is part of Purdue’s development program and plan to make nalmefene HCl injection available as quickly as possible to the patients who need it most. As part of the program, Purdue is developing nalmefene HCl injection as a generic product in vial and pre-filled syringe formats, and as an autoinjector through the 505(b)(2) pathway.
As part of Purdue’s ongoing commitment to advancing meaningful solutions to address the opioid addiction crisis, the company is working to bring forward these additional treatment options with the commitment not to profit from future sales of this drug.
“Purdue is committed to addressing the opioid addiction crisis, and our continued development of nalmefene HCl is one example of our ongoing efforts. Drug overdose deaths continue to rise in the United States, especially those involving synthetic opioids such as illicitly-manufactured fentanyl.1 There is an urgent and critical need for effective medications to treat overdoses associated with opioid abuse and addiction, which often result in loss of life,” said Craig Landau, MD, president and CEO, Purdue Pharma. “If developed successfully and approved by the FDA, Purdue will make this potentially life-saving treatment available as broadly and quickly as possible. As committed previously, Purdue will not profit from any future sales of nalmefene HCl injection.”
The first participant has now been enrolled and dosed in NAL1002, a Phase 1 study evaluating the pharmacokinetic and pharmacodynamic responses to various formulations of nalmefene HCl. The first part of this study will compare pharmacokinetic profiles from healthy adult male and female subjects following administration of nalmefene HCl intramuscularly and intravenously at various doses. Initial results from the study are expected in Q3.
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, nalmefene HCl injection has the potential to serve as an important alternative for the treatment of opioid overdose.
“We are pleased to initiate this new trial and continue advancing our understanding of nalmefene HCl,” said Richard Fanelli, PhD, vice president and head of Research and Development, Imbrium Therapeutics, a wholly-owned subsidiary of Purdue. “Opioid overdose deaths are a public health issue, driven largely by increasing abuse of extremely potent and long-lasting synthetic opioid agonists.1 We are working to develop an injectable form of nalmefene HCl as part of our commitment to making this important potential treatment option available to help patients facing life-threatening situations.”
Purdue has taken numerous actions to stem prescription opioid abuse in close collaboration with states, communities, industry partners, and law enforcement agencies. For additional information about Purdue’s commitment to addressing the opioid crisis, please read more about what we’re doing now.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete development or gain FDA approval.
About Purdue Pharma L.P.
Purdue Pharma and its subsidiaries develop and provide prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and are currently led by a physician. Beyond our efforts to provide quality medications, Purdue Pharma is committed to supporting national, regional and local collaborations to drive innovations in patient care while also continuing our efforts to address the opioid addiction crisis.
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 L.P., an investment vehicle focused on value-inflection in early stages of clinical development. For more information, visit www.purduepharma.com.
1 Centers for Disease Control and Prevention. Opioid
Overdose: Understanding the Epidemic. Accessed Jun 5, 2019. Retrieved
2 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/2019/03/13/fda-grants-purdue-pharmas-nalmefene-hcl-injection-fast-track-designation-for-the-emergency-treatment-of-known-or-suspected-opioid-overdose/.
3 Purdue Pharma L.P. 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. Apr 24, 2019. Accessed Jun 5, 2019. Retrieved from https://www.purduepharma.com/news/2019/04/24/fda-grants-competitive-generic-therapy-cgt-designation-to-purdue-pharmas-investigational-nalmefene-hcl-injection-for-the-emergency-treatment-of-known-or-suspected-opioid-overdose/.
4 National Institutes of Health. Drug Record: Nalmefene. Updated Oct 2018. Accessed Jun 5, 2019. Retrieved from https://livertox.nih.gov/Nalmefene.htm.