FDA Accepts Clinical Research Plan to Explore Senzer's Inhaler for Cancer Patients

LONDON, April 25, 2018 /PRNewswire/ --

The US Food and Drug Administration have accepted an application for a clinical development study on Dronabinol Inhalation using Senzer's unique breath-actuated inhaler, progressing the Company's US partner, INSYS Therapeutics, on its path for approval of the device as an innovative approach to help cancer patients, Senzer said (today).

INSYS, a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, said it had received notification that the FDA had accepted its filing for an Investigational New Drug for Dronabinol Inhalation. The approval means the clinical programme will now commence to explore chemotherapy-induced nausea and vomiting in adult cancer patients, whose response to conventional antiemetics has been sub-optimal. Researchers will also look at anorexia associated with weight loss in patients with AIDS under the IND application, and have plans to later expand the programme into anorexia in cancer and agitation in Alzheimer's disease.

"We are very excited that this milestone of IND acceptance has been achieved, and now look forward to working closely with the INSYS team on executing the clinical development programme," Senzer CEO Alex Hearn said. "Our novel device offers cancer patients a safe and effective means to reduce many of the negative and distressing effects of their treatment, and we look forward to generating the data to validate this approach."

INSYS are developing a pharmaceutical version of Dronabinol, a cannabinoid already approved by the FDA for chemotherapy-induced nausea and vomiting. The programme will aim to validate how this can be delivered through Senzer's proprietary inhaler, which offers an innovative way of ensuring a high uptake of pharmaceutical actives within a patient. Senzer says the handheld disposable device offers significant advantages over other delivery means, such as oral or IV.

"Senzer's proprietary inhalation technology involves no heat or combustion to deliver the therapeutic molecule to the distal lung, an important attribute in connection with Dronabinol, which requires an ambient temperature to maintain molecular stability," explained Venkat Goskonda, Senior Vice President of R&D for INSYS Therapeutics. "Our partner's hand-held device is actuated by the user's inhalation, obviating the need for the hand-breath coordination that is required with traditional metered-dose inhalers."