Drug delivery technology company Cure Pharmaceutical has entered into a product development agreement with Therapix Biosciences Ltd, a specialty, clinical-stage pharmaceutical company focusing on the development of cannabinoid-based treatments. The joint effort will formulate a proprietary cannabinoid-based product on CURE’s patented, multilayer oral thin film (OTF), CureFilm, for the treatment of a wide range of sleep disorders.
Under terms of the product development agreement, CURE will develop a formulation that combines 2.5 mg of dronabinol, a synthetic form of the key therapeutic cannabinoid endogenous to cannabis, 9-tetrahydrocannabinol (THC), and 200 mg of palmitoylethanolamide (PEA) on its OTF technology. This formulation constitutes the advancement of Therapix’s clinical development program focusing on sleep disorders, as recently announced in the agreement between Therapix and Assuta Medical Center in the initiation of a Phase IIa clinical trial in obstructive sleep apnea.
“We are enthusiastic about this next phase in our strategic partnership with Therapix. This product development agreement serves as testament that we are delivering on the goal we set forth when we first partnered in July to pool our expertise and resources to develop new products,” says CEO of CURE Rob Davidson in a release. “Our main goal at CURE is to improve people’s lives by redefining how medications are delivered, and sleep disorders is a medical indication with high unmet need that I think we can significantly impact.”
Repurposing the FDA-approved dronabinol using Therapix’s proprietary combination that exhibits the “entourage effect” is key to improving patient compliance and reducing unwanted side-effects, according to the companies. Ascher Shmulewitz, MD, PhD, executive chairman of Therapix, says, “Our goal at Therapix is to provide an optimized therapy for the treatment of a host of unmet medical needs, including sleep disorders, while reducing the dependence on more harmful drugs.”
Cure Pharmaceuticals has completed the feasibility study for this new product and will begin proof of concept in the coming weeks, with the overall goal of providing a deeper uninterrupted sleep for the 40 million people who suffer from sleep related disorders in the United States.