HQ Team
July 30, 2023: A not-for-profit US company, Harm Reduction Therapeutics’s ReVive has been allowed by the FDA to market its opioid overdose reversal drug without a prescription in the US.
The three-milligram naloxone hydrochloride nasal spray is used for the emergency treatment of known or suspected opioid overdose.
The company will make at least 200,000 doses, or 10% of its projected initial annual production, available for free. It can be used in an emergency situation to reverse the life-threatening effects of known or suspected opioid overdose.
Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for opioid overdose.
The drug will be available in the US by early 2024, according to the Bethesda, Maryland, US-based company.
No company, entity, or individual will profit from sales of RiVive. As a nonprofit pharmaceutical company, Harm Reduction will engage additional funding partners to help make its affordable opioid overdose treatment more accessible.
Not-for-profit
The partner funding will further lower the price of RiVive, making more of it available free to specific U.S. nonprofit harm reduction organizations.
It will also help to increase manufacturing capacity. Since 2017, more than 290,000 people across the U.S. have died due to an opioid overdose.
Harm Reduction Therapeutics is a 501(c)(3)nonprofit pharmaceutical company focused on increasing access to free or low-cost naloxone.
Its work has been funded by private donors and by contributions from Purdue Pharma approved since 2020 by the bankruptcy court administering Purdue Pharma’s Chapter 11 proceedings.
The drug will be available in twin packs containing two single-dose devices and it is safe to keep administering RiVive every two to three minutes until the person wakes up.
Catalent tie-up
RiVive is currently being produced under a commercial supply agreement with Catalent, a leading global contract development and manufacturing organization, at their facility in Morrisville, North Carolina.
Emergent BioSolutions got the USFDA’s green signal in March for the first over-the-counter drug Narcan, a naloxone-based spray.
In the 12-month period ending in February 2023, more than 105,000 reported fatal overdoses occurred which were primarily driven by synthetic opioids like illicit fentanyl, according to the FDA.
“The agency has long prioritized access to naloxone products, and we welcome manufacturers of other naloxone products to discuss potential nonprescription development programs with the FDA,” said FDA Commissioner Robert M. Califf.
