Patients Rising Now submitted comments to the Food and Drug Administration (FDA) on making naloxone available as an over-the-counter treatment. Naloxone is a treatment which prevents death in the event of an opioid overdose and is currently only available through prescription or in the event of an emergency. In the letter, PRN identified key statistics which point to lives which could have been saved had naloxone been administered as well as naloxone saving thousands of lives when administered in time. In addition to the letter, Patients Rising CEO Terry Wilcox offered verbal testimony on the proven benefits of access to naloxone and the increasing need for it to be available over-the-counter.
To go along with the open comment period, the FDA’s Nonprescription Drugs Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee held a joint meeting to determine if the available data support designating naloxone as an over-the-counter treatment. The full hearing can be found here with Terry’s testimony beginning at the 4:59:15 time code. The committees later unanimously voted to recommend over-the-counter status be granted to naloxone. The FDA plans to make its final decision no later than March 29.