Policy & Regulation
FDA Grants Purdue Pharma's Nalmefene HCl Injection Fast Track Designation for the Emergency Treatment of Known or Suspected Opioid Overdose
14 March 2019 - - The US Food and Drug Administration has granted Fast Track designation to nalmefene hydrochloride injection, US-based Purdue Pharma L.P.'s investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose, the company said.

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.

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.

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.

FDA granted Fast Track designation based on data in the company's Investigational New Drug application 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.

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 Pharma and its subsidiaries develop and provide prescription medicines. The company was founded by physicians and are currently led by a physician.

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 and related disorders, and Greenfield Bioventures, an investment vehicle focused on value-inflection in early stages of clinical development.