Insys Therapeutics Inc (NASDAQ:INSY) has issued an update on the naloxone nasal and epinephrine sprays and CBD oral solutions. CEO and President of Insys Therapeutics, Saeed Motahari said the company is focusing on novel drug delivery systems and pharmaceutical grade cannabinoids to drive the growth going forward. It is moving away from opioids. The company is transforming its business strategy to include patient-centric formulations over the past one year. Going forward, Insys Therapeutics is preparing to submit 6 innovative drug applications in the next 3 years. The company is scheduling two of them in 2019.
An update on the Opioid Related Assets
As per the announced plans, Insys Therapeutics is scheduling the alternative review of the opioid related assets. As of now, nine firms have entered into a pact with Insys Therapeutics and are reviewing the confidential information. The company will release an update on this aspect in early 2019.
An Update on the Lifesaving Products
Insys Therapeutics is in the advanced stages of developing the lifesaving investigational products that are based on spray technologies. Its lifesaving products in development include epinephrine nasal spray for anaphylaxis and naloxone nasal spray for the opioid overdose.
The company is also focusing on cannabinoids like CBD oral solution targeting the child absence epilepsy treatment (phase 2), Prader Willi Syndrome (phase 2), infantile spasms (phase 3), and dronabinol inhalation to treat a variety of conditions such as anorexia in patients suffering from cancer.
Insys Therapeutics is conducting a non-clinical toxicity study on naloxone nasal spray and expects to announce the results in March 2019. The company has set the timeframe for the NDA submission in Q1 2019.
Epinephrine nasal spray, which is intended for needle-free delivery, is a substitute to the intramuscular injection. According to the study, it is readily absorbed via the nasal mucosa. The company has obtained FDA nod for fast track designation for the drug in August 2018. It has also provided specific guidelines for filing requirement and clinical development. Insys Therapeutics is optimistic to complete the filing requirements for epinephrine NDA in Q4, 2019. It is subject to successful completion of PK study.
The company has successfully completed a proof of concept study on dronabinol inhalation in September 2018. Insys Therapeutics will arrange a meeting with clinical experts in Q1 2019 to discuss further development for this investigational formulation.
Insys Therapeutics Signs a Pact with Lunatus for Commercializing SUBSYS
Insys Therapeutics has signed a definitive accord with Lunatus for commercializing Subsys in 8 nations in the Middle East. Following the deal, Lunatus will act as an authorized agent and licensee in the UAE, Lebanon, Kuwait, Jordan, Saudi Arabia, Qatar, Oman, and Bahrain.