According to Lightlake Therapeutics, initial results from a two-week PK study of intranasal naloxone for the treatment of opioid overdose shows that the nasal spray gets naloxone into the bloodstream as fast as injection. The study, which began September 23, 2013, was conducted in conjunction with the National Institute on Drug Abuse (NIDA).
Lightlake CFO Kevin Pollack said, “Given our collaboration with NIDA and current understanding of the regulatory pathway with respect to our prospective opioid overdose reversal product, we anticipate incurring relatively low costs to reach an NDA submission with the FDA. Upon the prospective approval and launch of our product, we expect significant market demand given the growing opioid addiction epidemic and the multiple substantial advantages of our intranasal delivery of naloxone over the current injectable delivery of naloxone.”
CEO Roger Crystal indicated that the company intends to submit and NDA sometime in 2014. The company is also developing naloxone nasal spray for the treatment of binge eating disorder and for bulimia nervosa.
Read the Lightlake press release.
