LONDON, March 9, 2020 /PRNewswire/ -- Senzer has secured the Investigational New Drug application and data package for its ongoing FDA registration programme from its former US strategic partner and will now push ahead to get its cannabinoid respiratory device approved for treating side effects induced by anti-cancer treatments in the world's largest pharmaceutical market, the Company said today.
Work commenced on a 505(b)(2) clinical programme approval pathway more than four years ago to use Senzer's device for the treatment of side effects linked to chemotherapy, specifically nausea and vomiting, and neuropathic pain. However, the US licensee, Insys Therapeutics has since gone into administration. Senzer has now assumed full rights to the data package and all supporting documents for the IND.
The IND data package includes all work to date, namingly FDA-registered safety, tolerability and bioequivalence studies. The package also holds Phase I clinical results, which Insys has reported to be positive, with cannabinoids delivered via Senzer's proprietary inhalation device shown to be well tolerated in trials of healthy subjects. The study compared oral administration of Marinol, an approved synthetic form of the cannabinoid THC (dronabinol) as an anti-emetic, compared to Senzer's inhaled dronabinol. The study showed that Senzer's inhaled dronabinol, proved to be swiftly and effectively taken up into the bloodstream, reaching maximal plasma concentration within 2 minutes compared with 1.53 hours through Marinol oral administration. Additionally, Senzer's inhaled formulation proved to require significantly less (14 times less) dronabinol compared to Marinol -- 0.35mg inhaled versus 5mg oral administration -- to achieve similar plasma concentrations.
"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," said Senzer CEO Alex Hearn. "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 programme back on track again."
Senzer's breath-activated device is supported by more than 400 patents, and delivers a standard dose of cannabinoid formulations from a pressurised cannister, ensuring the reactive compounds are well protected from heat, light and oxygen. Senzer already has approval in Europe as a Class II(a) medical device, and will shortly be available in the UK and EU markets as an unlicensed medicine to address any individual clinical need of a patient when a suitable licensed medicine is not available. The device will also be provided through the world's largest medical cannabis usage project, Twenty21, which aims to treat some 20,000 UK patients with cannabinoids for six conditions.
SENZER Ltd. is a U.K.-based inhalation technology company specializing in the development and commercialization of therapeutic delivery systems of cannabinoid products, and it is developing a pipeline of inhalation and delivery products to meet unmet medical needs. Senzer's platform is based around a patented device that allows swift and effective inhaled delivery of cannabinoids, in a consistent dose-controlled presentation.