According to Senzer, the company has obtained the IND application and data package for its inhaled dronabinol from its former partner, Insys Therapeutics, and will now move ahead with development for the treatment of side effects from chemotherapy and for neuropathic pain. Insys filed for bankruptcy in June 2019.
Senzer partnered with Insys in 2015 to develop inhaled dronabinol and cannabidiol products delivered via Senzer’s inhalation device. In April 2018, Insys announced that it would begin Phase 1 clinical development of the dronabinol inhaler; positive results from a PK study were announced in September 2018. According to Senzer, results from that trial are included in the IND data package.
The Senzer breath activated delivery device received received Class IIa Medical Device approval for the “safe and effective delivery of pharmaceutical cannabinoids” in Europe in September 2019. In July 2018, the company announced plans for launches of its Cannafen cannabidiol inhaler in addition to the Candex dronabinol inhaler. Senzer now says that the inhaler will soon be available in the UK and EU as an unlicensed medicine, and the device will be available through the Twenty21 medical cannabis project.
Senzer CEO Alex Hearn said, “Securing the IND package will allow us to build on all the quality work to date, and means we can now go straight into resolving clinical trials to explore further how our unique approach can help those suffering from chemotherapy side effects. We have always looked to the US as a key market we wish to enter, and I know my team are very excited to be getting our FDA approval program back on track again.”
Read the Senzer press release.
