Insys Therapeutics Inc (NASDAQ: INSY)
Insys Therapeutics investors had every reason to celebrate on Thursday, after the company received a Fast Track designation for one of its investigational treatments from the U.S. Food and Drug Administration (FDA). In a press statement released early this morning, the company said it received the designation for its epinephrine nasal spray as an investigational treatment for anaphylaxis.
“The receipt of Fast Track designation represents a significant milestone for INSYS and our clinical development of this novel drug-device combination. We look forward to working with the agency to make it available to those who may be interested in an alternative to intramuscular auto-injectors as soon as possible,” commented Steve Sherman, Insys Therapeutics’ senior vice president of regulatory affairs.
The announcement generated excitement investors, sending the shares on a run for the top. INSY stock gained $2.89, or 36.24% to trade at $10.60 during the late hours of regular trading. Analysts believe the stock could continue moving upwards for a while. The shares have now climbed 5.4% since the beginning of the year, while the S&P 500 has jumped nearly 8.9%.
Anaphylaxis is a life-threatening allergic reaction that requires urgent treatment. The company said that during the previous the clinical investigation, the epinephrine nasal spray showed positive signs of a “potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection” for treating the allergic reaction.
A Fast Track designation means that the company will now work more actively with the regulator in order to have the product approved. The designation also brings in other benefits, such as allowing the firm to forward its New Drug Application (NDA) quickly instead of having to wait for months or possibly years for the full application package.
Insys Therapeutics, Inc. Company Profile
Insys Therapeutics, Inc., is a specialty pharmaceutical company that is engaged in the development and commercialization of supportive care products. The company markets SUBSYS, a sublingual fentanyl spray for breakthrough cancer pain in opioid-tolerant adult patients. It also sells SYNDROS, an orally administered liquid formulation of dronabinol for the treatment of chemotherapy-induced nausea and vomiting, and anorexia associated with weight loss in patients with AIDS.
In addition, the company is developing Cannabidiol Oral Solution, which has completed pediatric study for the treatment of pediatric epilepsy; has completed Phase II study to treat west syndrome; and is in Phase II study for the treatment of childhood absence epilepsy, as well as Buprenorphine Sublingual Spray that has completed Phase III study to treat acute pain.
Further, the company is developing Cannabidiol Oral Solution for the treatment of prader willi; Buprenorphine/Naloxone Sublingual Spray to treat opioid dependence; as well as Naloxone Nasal Spray for the treatment of opioid antagonist.
Insys Therapeutics, Inc. competes with Galena Biopharma Inc., Par Pharmaceutical Companies, Teva Pharmaceutical Industries Ltd, Depomed Inc., Actavis, Inc., Mallinckrodt, Inc., and BioDelivery Science International, Inc. The company is headquartered in Chandler, Arizona. It was founded on June 15, 1990 and by John N. Kapoor. –YahooFinance