According to Lightlake Therapeutics, the company has signed a contract with a manufacturer for commercial production of its intranasal naloxone for the reversal of opioid overdose. In December 2013, the company announced positive initial results from a PK study of the product and said that it planned to submit an NDA in 2014.
Lightlake CEO Roger Crystal commented, “This is a significant milestone for Lightlake in forwarding our opioid overdose reversal treatment. We have been diligent in selecting our partner for the contract manufacturing process to best position us to produce a high quality treatment that can meet the requirements for FDA approval. We are confident that working with this partner will help us better serve the market need for a needleless treatment and provide us with significant competitive advantages.”
CFO Kevin Pollack added, “We are very pleased with the high quality of our partner involved in the contract manufacturing process. Our partner has the capacity to produce significant quantities of our intranasal naloxone spray at a reasonable cost, which could facilitate our scaling up production to address a growing population of potential users of our treatment and should save more lives.”
Lightlake partnered with the US National Institute on Drug Abuse (NIDA) for the 2013 clinical trial of the product for the treatment of overdose. The company is also developing intranasal naloxone for the treatment of binge eating disorder and for bulimia nervosa.
Read the Lightlake Therapeutics press release.
