Lightlake Therapeutics has announced that it filed an investigational new drug application for its intranasal naloxone therapy for the reversal of opioid overdose. The company also said that it has received additional funding from the National Institute on Drug Abuse (NIDA) for a new clinical trial of the product. Lightlake recently said that it had signed a manufacturing contract for its naloxone spray.
The new study will be the company’s second in collaboration with NIDA, which sponsored a 2-week Phase 1 pharmacokinetic study in 2013. According to Lightlake, the additional commitment from NIDA will allow the company to “evaluate its technology on a larger population.”
Lightlake CEO Roger Crystal commented, “We are extremely pleased that NIDA has continued its support of our opioid overdose reversal treatment. This support demonstrates NIDA’s commitment of having an FDA approved intranasal naloxone nasal spray available to the public.”
CFO Kevin Pollack added, “NIDA’s continued commitment to advancing our overdose reversal treatment reflects their confidence in the potential of our treatment. We believe that our treatment can make a huge difference in addressing the overdose epidemic and save a significant number of lives, and NIDA’s support plays a critical role in achieving our goals.”
Read the Lightlake press release.
