FDA Grants Purdue Pharma’s Nalmefene HCl Injection Fast Track Designation for the Emergency Treatment of Known or Suspected Opioid Overdose

Committed to advancing solutions to the opioid public health 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) has granted Fast Track designation to nalmefene hydrochloride (HCl) injection, the company’s investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose. This designation comes at a time when 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.¹ The FDA’s Fast Track designation facilitates the development, and expedites the review, of new therapies that treat serious conditions and fulfill an unmet medical need, with the purpose of getting important new treatments to those in need earlier.²

Nalmefene HCl has a longer duration of effect than naloxone, another opioid antagonist currently approved for emergency treatment of known or suspected opioid overdose.³ 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.

As part of Purdue’s commitment to advance meaningful solutions to address the opioid crisis, the company will work to bring forward this option with the commitment not to profit from any future sales of this drug. Purdue is currently exploring a number of options to ensure nalmefene HCI is developed for and accessible to the people who need it most.

“Fentanyl and illicit opioid deaths continue to increase in the United States, fueled increasingly by overdoses of this class of compounds. We urgently need new and potentially more effective treatments to combat opioid overdose than are available today,” said Craig Landau, MD, president and CEO, Purdue Pharma. “The Fast Track designation from the FDA for nalmefene HCl underscores the importance and time sensitivity of this unmet medical need. We will continue our efforts to make nalmefene HCl injection available as quickly as possible, as it has the potential to be an important option to help address this public health emergency.”

FDA granted Fast Track designation based on data in the company’s Investigational New Drug application (IND) of nalmefene HCl for the emergency treatment of known or suspected opioid overdose, as well as the anticipated efficacy and safety data from our planned clinical studies. The company’s IND for nalmefene HCl injection became effective on January 16, 2019. There is no guarantee that nalmefene HCl injection, an investigational agent, will successfully complete clinical development or gain FDA approval.

“Opioid antagonists like naloxone have played an important role in the emergency treatment of opioid overdose. However, because of the increasing number of deaths due to fentanyl and its even more potent analogues, we are focusing on a potentially more potent and longer-lasting rescue option specifically intended to work in those overdose situations,” said John Renger, PhD, vice president, head of Research & Development and Regulatory Affairs, Purdue Pharma. “If approved, this injectable form of nalmefene HCl could represent an important alternative to current opioid antagonists used by first responders and non-medically trained individuals who come upon a person experiencing an opioid overdose. We are pleased to receive a Fast Track designation by the FDA and to have the opportunity to work closely with the Agency to make this investigational rescue medicine available as quickly as possible.”

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.

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 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, an investment vehicle focused on value-inflection in early stages of clinical development. For more information, visit www.purduepharma.com.

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References

¹ Centers for Disease Control and Prevention. Opioid Overdose: Understanding the Epidemic. Accessed Feb 28, 2019. Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html.
² U.S. Food and Drug Administration. Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review: Fast Track. Accessed Mar 6, 2019. Retrieved from https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm.
³ National Institutes of Health. Drug Record: Nalmefene. Updated Oct 2018. Accessed Mar 7, 2019. Retrieved from https://livertox.nih.gov/Nalmefene.htm.