Profile: INSYS Therapeutics Inc (INSY.OQ)
Insys Therapeutics, Inc., incorporated on June 15, 1990, is a commercial-stage specialty pharmaceutical company. The Company develops and commercializes supportive care products. Subsys is the Company's marketed product. Subsys is a sublingual fentanyl spray for breakthrough cancer pain (BTCP) in opioid-tolerant patients and is a single-use product that delivers fentanyl, an opioid analgesic, for transmucosal absorption underneath the tongue. The Company markets Subsys through its field sales force focused on supportive care physicians in the United States.
Subsys Sublingual Fentanyl Spray
The Company's product, Subsys, delivers a liquid fentanyl formulation in approximately 100, 200, 400, 600, 800, 1,200 and 1,600 micrograms (mcg) dosages. The mechanism, by which the liquid is delivered, is a one-step process, in which a plume of fentanyl is generated by the actuation of the device. The plume disperses a small volume of liquid across the surface area of the sublingual mucosa and facilitates rapid absorption by the body.
Cannabinoid Product Family
The Company's lead dronabinol product candidate is Syndros, which is under review for approval at the Food and Drug Administration. In addition, the Company is evaluating sublingual spray, inhaled and intravenous formulations of dronabinol in preclinical studies. Dronabinol is a synthetic form of delta-9-tetrahydrocannabinol (THC). THC is an orally active cannabinoid. The Company is developing Syndros for the treatment of chemotherapy-induced nausea and vomiting (CINV) and appetite Stimulation in acquired immuno deficiency syndrome (AIDS) patients.
Cannabidiol Oral Solution
The Company is developing a Cannabidiol Oral Solution, a synthetic cannabidiol, for childhood catastrophic epilepsy syndromes focusing on Dravet syndrome, Lennox-Gastaut syndrome and Infantile Spasms. The Company is conducting approximately two studies in epilepsy: a Phase Ib pharmacokinetic study that is evaluating over three different doses of synthetic cannabidiol (CBD) in pediatric patients with refractory epilepsy, and a second study, a Phase II study to assess the efficacy and safety of Cannabidiol Oral Solution for the treatment of refractory infantile spasms.
Other Product Candidates
The Company's other product candidates include other dronabinol line extensions and sublingual spray product candidates. The Company's product candidates also include Buprenorphine Sublingual Spray for acute and chronic pain; Buprenorphine/Naloxone Sublingual Spray for opioid dependence; Naloxone Sublingual Spray as opioid antagonist; ondansetron sublingual spray for nausea and vomiting in cancer chemotherapy, and Liposomal Encapsulated Paclitaxel (LEP) for the treatment of gastric cancer and cervical cancer
The Company competes with Teva Pharmaceutical Industries Ltd, Galena Biopharma Inc., Depomed Inc., BioDelivery Science International, Inc., Mallinckrodt, Inc., Par Pharmaceutical Companies and Actavis, Inc.
INSYS Therapeutics Inc
10220 S 51st St Ste 2
PHOENIX AZ 85044-5231
Company Web Links
- BRIEF-Insys announces Saeed Motahari to become president and CEO
- BRIEF-Insys Therapeutics Drug Enforcement Agency issued an interim final rule
- BRIEF-Neopharm to pay annual dividend as 350 won/share for FY 2016
- Insys to pay $3.4 million to resolve New Hampshire fentanyl drug probe
- BRIEF-Insys Therapeutics announces retirement of Dr. John Kapoor as CEO