Harm Reduction Therapeutics Inc. is taking a nonprofit approach to a naloxone OTC switch with a goal of offering it in “every drug store in America" to help prevent opioid-related deaths, says founder and CEO Michael Hufford.
Hufford said the Pittsburgh firm seeks to raise $10m funding to conduct research for an OTC switch application and eventually launch a naloxone product at a low cost with broad availability in some 110,000 retail locations, including 35,000 drug stores as well as gas stations and convenience stores
Response To FDA Push
Harm Reduction Therapies targeted a naloxone OTC switch after FDA Center for Drug Evaluation and Research officials said at a May 2017 consumer health regulatory conference that the agency had funded labeling studies about OTC use, assessing whether pictograms could show “how to safely use naloxone, including when it is appropriate to purchase it and how to use it in an emergency." Division of Nonprescription Drug Products Director Theresa Michele said the research could spur industry interest in resolving unmet public health need and encouraged manufacturers to correspond with the agency regarding potential switch applications. (Also see "FDA's OTC Naloxone Study Is A Starting Point For Other Switches, Not A Roadmap" - Pink Sheet, 16 May, 2017
