MediQuest Therapeutics, a Bothell, WA-based developer of a drug for Raynaud’s disease, said the FDA has turned down its application to market the product in the U.S.
The FDA said the company’s application to market Vascana, a squeeze-on gel to improve blood circulation in the hands and feet, “could not be approved in its present form,” according to an e-mailed statement from the company. The FDA identified issues that the company needs to address before it can receive clearance for marketing, and Mediquest said it plans to discuss the issues with the agency.
“There is not a lot to say except that we need to speak with the FDA to get clarity on the outstanding issues and see what we need to do to resolve them,” said Fred Dechow, Mediquest’s CEO, in an e-mail.
The FDA gave MediQuest an expedited six-month review of the product, which it sometimes provides for unmet medical needs. As I wrote in a profile of the privately-held company in July, Raynaud’s is a condition of limited blood circulation that causes numbness in the fingers and toes in cold temperatures. Usually, it means people with the condition have to avoid the ice cream aisle at the grocery store, or wear a pair of gloves. An estimated 2.1 million people, mostly women, have sought medical treatment for the condition, Dechow said.
The Vascana gel, which is squeezed on the fingers with a spongy material the size of a quarter, showed improvement in a patient-reported scoring system that measured the number of Raynaud’s flare-ups, how long they lasted, and the severity of pain, numbness, and tingling, said Jeffrey Gregory, the company’s chief medical officer, in an interview in July. The drug application was based on two primary clinical trials. One showed Vascana was 13 percent better than the placebo, and the other showed a 24 percent improvement with the drug, he said.