Purdue Pharma gives $9M to Harm Reduction Therapeutics for opioid overdose reversal meds

Key Takeaways:

• $9 million in funding for commercial readiness was approved by the Bankruptcy Court.

• RiVive over-the-counter naloxone spray was recently granted priority review by FDA.

Purdue Pharma announced it plans to provide up to $9 million in additional financial support for a low-cost over-the-counter intranasal naloxone spray.

According to a release from Purdue Pharma, the move was approved by U.S. Bankruptcy Court and will allow Harm Reduction Therapeutics, an independent 501(c)(3) nonprofit pharmaceutical company, the necessary funds to advance its purpose of making RiVive (naloxone), its OTC nasal spray, available to the public. Purdue Pharma has provided financial contributions, technical expertise and rights to data to Harm Reduction Therapeutics since 2018, according to the company.

“We are grateful to our creditors for their support of this important effort to help abate the opioid crisis and save lives by making naloxone nasal spray more accessible and affordable,” Craig Landau, MD, president and CEO of Purdue Pharma, said in the release. “We appreciate FDA’s support of the development of OTC naloxone products that will expand access to this lifesaving medication.”

The FDA accepted and granted priority review to HRT’s new drug application for its naloxone spray in December. Harm Reduction Therapeutics said in the release it anticipates an approval decision from the regulatory body in July, and pending that approval, expects to launch in the U.S. by early 2024.

“With growing support among both the public and government health agencies toward expanding naloxone access with OTC products, we are on the brink of a major inflection point in our mission to prevent opioid overdose deaths,” said Michael Hufford, PhD, co-founder and CEO of Harm Reduction Therapeutics.