|Insys Therapeutics Inc (NASDAQ:INSY) Submits NDA for Dronabinol Oral Solution|
|By Josh Gee|
|Wednesday, 03 June 2015 07:41|
Insys Therapeutics Inc (NASDAQ:INSY) has confirmed submission of a New Drug Application to U.S. Food and Drug Administration (FDA) for the proprietary Dronabinol Oral Solution for weight loss in patients with AIDS along with vomiting associated with cancer chemotherapy in some patients having failed to respond appropriately to usual antiemetic treatments.
Dronabinol Oral Solution is an orally administered liquid formulation of the pharmaceutical cannabinoid dronabinol
Michael L. Babich, President and Chief Executive Officer, opined that the firm is glad to have re-submitted NDA Dronabinol Oral Solution that was made easy through obtaining of FDA agreement with relevant pediatric study plan.
He added that Dronabinol Oral Solution may be a vital option for patients facing problems from bad effects of chemotherapy induced nausea as well as for those fighting anorexia associated with AIDS.
Insys is expecting that the fresh DEA-inspected facility in Round Rock, Texas would allow it to make huge quantities of pharmaceutical-grade cannabinoid products along with Dronabinol Oral Solution as well as pharmaceutical cannabidiol for research needs.
The Company got Refusal to File letter in October last year for the earlier given NDA for Dronabinol Oral Solution as submission had an inadequate pediatric study plan for conducting studies to assess safety as well as efficacy.
The Company is anticipating current NDA for a substantive review by the FDA and aims to continue working with FDA throughout review process.
Insys Therapeutics is a pharmaceutical company which commercialises and develops innovative drugs as well as novel drug delivery systems of therapeutic molecules which aid in improving quality of life of patients.
Shares of INSY were closed higher 1% to $59.60.