Insys Submits NDA For New Oral Formulation Of Dronabinol, Q2 Profit Surges

(RTTNews) - Insys Therapeutics, Inc. (INSY) Tuesday said it has submitted a New Drug Application to the U.S. Food and Drug Administration for its proprietary Dronabinol Oral Solution for anorexia associated with weight loss in patients with AIDS; and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond sufficiently to conventional antiemetic treatments.

The company also announced second-quarter results, which showed a significant increase in profit and revenue. The stock added over 8 percent in pre-market activity.

The company is a specialty pharmaceutical company developing and commercializing innovative drugs and novel drug delivery systems.

Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol, a synthetic version of tetrahydrocannabinol.

Michael Babich, CEO, said, "Based on early research, we believe Dronabinol Oral Solution has the potential to offer a treatment option with distinct advantages over generic dronabinol capsules including a faster rate of absorption, more consistent blood levels, and the ability to titrate to effect."

The company believes that Dronabinol Oral Solution can become an important new option for patients suffering from the devastating effects of chemotherapy induced nausea and vomiting, as well as those fighting anorexia associated with AIDS.

The firm also announced second-quarter financial results. Net income increased to $9.5 million, or $0.26 per share, from $4.5 million, or $0.17 per diluted share, for the second quarter of 2013.

After adjusting for stock compensation expense, adjusted net income was $0.58 per share, while it totaled $0.24 per share last year.

Two analysts polled by Thomson Reuters expected earnings of $0.30 per share for the quarter. Analysts' estimates typically exclude special items.

Total net revenue increased to $55.7 million from $18.8 million for the second quarter of 2013. Analysts expected revenues of $52.77 million.

Revenues from Subsys or fentanyl sublingual spray surged to $54.6 million from $18.5 million last year.

The firm said it is also advancing its CBD candidate, for which the FDA granted Orphan Status in the treatment of Lennox-Gastaut Syndrome and Dravet Syndrome.

INSY, which closed up 7.6 percent at $30.42 on Monday, is gaining 8.3 percent in pre-market activity.