OTC Naloxone Nasal Spray Biocompatibility Study Funded In US From Purdue Pharma Bankruptcy

Up to $6.5m funding will completely cover Harm Reduction Therapeutics' costs for a Phase 1 study, preparation of an NDA and commercial launch production. The study, a standard Phase 1 biocompatibility trial with around 30 subjects, should be completed in a few months later this summer.

Harm Reduction Therapeutics Inc. clears a major hurdle to submitting a US proposal for an OTC naloxone nasal spray with up to $6.5m made available in Purdue Pharma LP’s bankruptcy proceeding to pay for a Phase 1 study of the product.

“In developing a low-cost OTC naloxone product, we have the opportunity to significantly expand access to this potentially lifesaving medication. Purdue’s support has been crucial to our work as we look to provide a meaningful breakthrough in this ongoing public health crisis,” said Michael Hufford, co-founder and CEO of HRT, a nonprofit based in Pittsburgh.

Hufford told HBW Insight on 23 June that the funding will completely cover HRT’s costs for a Phase 1 study, preparation of a new drug application to submit to the Food and Drug Administration and to prepare for commercial launch production. With FDA approval of its application, HRT would need "a much larger financing commitment" to pay for production, he said.

FDA Support Clear

Expanded naloxone availability is recommended by the US Surgeon General and the Department of Health and Human Services as well as the FDA.

The FDA in January 2019 underscored its interest in proposals for allowing OTC access to naloxone with the unprecedented step of developing model Drug Facts labels that potential sponsors can use for their own label comprehension studies. (Also see "FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals" - HBW Insight, 17 Jan, 2019.)

On the same day, the FDA announced that a study of making naloxone available OTC study supported the model DFLs it designed. A report on the study of label comprehension for OTC use of nasal spray and auto-injector products, the two forms of the drug currently available Rx-only "in consumer-friendly format." showed the model DFLs were well-understood by consumers and are acceptable for use by manufacturers in support of new drug applications of making naloxone available OTC. (Also see "FDA's OTC Naloxone Model Labels Confirmed In CONFER Study" - HBW Insight, 17 Jan, 2019.)

The study with the opioid antagonist indicated for complete or partial reversal of opioid overdose including respiratory depression will be a standard Phase 1 biocompatibility trial with around 30 subjects and should be completed later this summer.

As a drug off-patent since 1985 and with a strong safety record since launching in the US in 1971, the FDA doesn't have questions on naloxone’s safety or efficacy profile, Hufford said. In pre-proposal meetings, agency officials advised the firm on studies needed for its NDA.

"The FDA confirmed that the only a bioequivalence study would be needed to show that our nasal spray is biocompatible with an existing naloxone product," he said.

According to the Centers for Disease Control and Prevention, US drug overdose deaths decreased by 4% from 2017 to 2018. Still, drug overdoses in 2018 were the leading cause of injury-related US deaths at more than 67,000; of those deaths, almost 70% involved a prescription or illicit opioid.

A study published earlier in 2020 in the Journal of the American Medical Association found that an Ohio law allowing pharmacists to provide naloxone without a prescription led to a 2,328% increase in orders dispensed in the state. Researchers, using data from all 88 counties in the state from July 2014 through January 2017, found the monthly rate of orders for naloxone dispensed per county after the policy was implemented increased by 4% in the Ohio Medicaid population and 3% among the Kroger Pharmacy population.  (Also see " Ohio Study Shows Access To Naloxone Soars Without Rx Requirement" - HBW Insight, 11 Feb, 2020.)

Bankruptcy Proceeding Allows Support For HRT

The agreement to provide additional funding to HRT was approved the same day during a hearing in Purdue Pharma’s Chapter 11 bankruptcy protection proceeding in US Bankruptcy Court for the Southern District of New York. The firm, which makes OxyContin (oxycodone) and other opioids indicated for relieving chronic pain but frequently diverted to users who abuse the powerful drugs, proposed in its filing to spend $10bn on developing nalmefene addiction treatment medication as well as on naloxone products. (Also see "Purdue's Support For OTC Naloxone Would Continue In Bankruptcy " - HBW Insight, 22 Sep, 2019.)

In 2018, it made a $3.42m grant to HRT, which launched the same year targeting reducing opioid overdose deaths by making low cost naloxone widely available in 110,000 locations, including drug stores, gas stations and convenience stores. (Also see "Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue" - HBW Insight, 6 Sep, 2018.)

Consistent with previous commitments, Purdue is not expected to receive revenues, royalties, or profits associated with potential future sales of an HRT OTC naloxone nasal spray.

The Stamford, CT-based firm has been criticized for making billions selling the drugs linked to thousands of opioid-overdose-related deaths across the US and stopped actively marketing opioids by February 2018 before filing for bankruptcy September 2019 to protect its owners from federal and state lawsuits it faces alleging liability for the problem.

Hufford noted that other drug firms' revenues from sales of FDA-approved opioid-containing drugs far outstrip HRT’s total budget from launch to NDA submission.

“With that money we could get OTC naloxone developed, submitted, approved and distributed to every drug store in American, with sheriff departments and emergency medical technicians receiving it for free,” he said.