In an effort to address the opioid crisis in the country, the Food and Drug Administration (FDA) has granted approval to Harm Reduction Therapeutics’ RiVive, making the over-the-counter (OTC) naloxone nasal spray product the second such product and the first generic non-prescription naloxone drug to attain the status.
FDA’s Response to the Opioid Crisis
- FDA reports over 100,000 fatal overdoses in the past year, with synthetic opioids, including illicit fentanyl, being the primary cause.
- Approval of over-the-counter (OTC) naloxone aims to reduce opioid-related fatalities and offer immediate aid during opioid overdoses.
The spray created by the non-profit has been approved by the agency for the emergency treatment of known or suspected opioid overdose. The spray works by preventing the addictive effects of opioids by blocking opioid receptors. This way, naloxone is able to prevent opioid overdoses. The only side effects identified for the drug so far include fever, body aches, diarrhea, and more.
The non-profit has announced that the drug will be available to state governments and US harm organizations by early next year and at lower prices too. Harm Reduction Therapeutics aims to provide the nasal spray at costs lower than other opioid antagonist nasal sprays, and in order to achieve this, is calling on its funding partners to direct any financial support to reduce the drug’s price.
Harm Reductions has also requested funding partners to assist with improving the drug’s accessibility and improving manufacturing capacity. RiVive has been developed under a collaboration between Reduction Therapeutics and US-based Catalent.
Both firms entered a commercial supply agreement under which Catalent will manufacture the therapy at its inhalation development facility in Morrisville, North Carolina. The facility sprawls across 180,000 ft² of land.
The US-based non-profit organization also shared in a press release that no firm, individual, or entity will profit or benefit from sales of RiVive. In fact, the organization has announced that the first 10% of projected initial annual product production, which is around 200,000 doses, will be provided free of cost.
Prior to RiVive’s approval in July, the FDA granted approval to Narcan by Emergent Biosolutions in March, who have also demonstrated their commitment to providing the drug for cheaper in an announcement that came in April.
Other attempts by the FDA to combat the opioid crisis include expanding options for opioid disposal through the progression of its overdose prevention framework and the implementation of a mail-back envelope system.
