Bankruptcy court clears Purdue to fund low-cost opioid rescue medication

A bankruptcy court has boosted Harm Reduction Therapeutics’ (HRT) bid to develop a low-cost opioid rescue medication. With the court handling Purdue Pharma’s case approving the transfer of cash to HRT, the nonprofit drug developer is set to receive up to $11 million.

Purdue began supporting HRT’s development of an over-the-counter naloxone nasal spray in 2018 by providing cash, technical expertise and rights to data to aid development of a candidate that is expected to sell at a “substantially lower retail cost” than existing rescue medications.

The bankruptcy court has now authorized Purdue to provide HRT with up to $11 million. In keeping with the terms of the original agreement, neither Purdue nor its creditors will profit from future sales of a product designed to shake up the opioid rescue market.    

“The American Medical Association has called on the federal government to remove the prescription status of naloxone to make it more available over the counter. However, access to naloxone remains a challenge for many communities in the U.S. We believe that this medicine, if it receives FDA approval, has the potential to make naloxone nasal spray more accessible and affordable,” Purdue CEO Craig Landau said in a statement. 

Buoyed by the financial support, HRT plans to file a new drug application for its nasal spray with the FDA this year. The FDA has taken steps to encourage the development of OTC naloxone, notably through its development of a model Drug Facts label to help companies meet a requirement for OTC products.