Insys’ Application for Dronabinol Oral Solution Rejected by the FDA
Insys Therapeutics recently announced that the US Food and Drug Administration (FDA) has rejected its application for Dronabinol oral solution for submitting an inadequate or incomplete pediatric study plan.
The company said that it received a Refusal to File Letter from the agency for its New Drug Application (NDA) for its proprietary Dronabinol oral solution, causing shares to fall about ten percent. Insys said that it believes that the information required is available, and the company will not need to conduct further clinical studies to address the pediatric study plan requirement.
Insys had filed the NDA for the oral solution in August 2014. The company said that it is working closely with the FDA to resubmit the NDA as quickly as possible.
“We will work closely with the FDA to fully address the incomplete pediatric study plan and define a path forward for a successful resubmission of this NDA as soon as possible,” said Michael L. Babich, President and Chief Executive Officer of Insys. “We have had constructive dialogue with the FDA throughout this process and we are confident in our ability to address the agency’s request and resubmit rapidly as we believe no additional studies are required to address the incomplete pediatric plan, which was the only item cited as the cause for the refusal to file.”
Separately, Insys said that its FDA-inspected and Drug Enforcement Agency (DEA) approved facility in Round Rock, Texas has received DEA approval to manufacture synthetically its pharmaceutical grade Cannabidiol (CBD). The company has been cleared to manufacture up to 15 kilograms of CBD in 2014, and expects that number to increase in 2015 for its continued clinical studies.
Insys intends to file an investigational new drug application in December for use of its CBD in patients with two rare forms of pediatric epilepsy, Dravet syndrome and Lennox-Gastaut syndrome.
“We are excited to initiate our clinical development of CBD in these pediatric patients, for whom current treatments are insufficient. We plan to dose our first human subject in the first quarter of 2015 in a Phase I setting,” said Insys’ President and Chief Executive Officer, Michael L. Babich. “Numerous investigators are waiting to receive our finished pharmaceutical dosage product to study several other potential indications for CBD. With DEA approval to manufacture CBD in hand, we are now in a position to supply product to these investigators.”
Source: Insys Therapeutics, Inc.
Last updated: 10/21/14; 11:40am EST
