SOUTH SAN FRANCISCO, Calif. (
) -- The U.S. Food and Drug Administration came down hard on
, rejecting its Probuphine implantable therapy for opioid dependence and requesting a lot of new clinical data and other information before the company can resubmit.
Titan shares reacted as you'd expect -- down 73% to 44 cents in Wednesday trading.
Titan said it was "surprised and disappointed" in the FDA's Complete Response Letter but remains committed to addressing the agency concerns and getting Probuphine approved. The company and its partner Braeburn Pharmaceuticals intend to meet with the FDA to clarify exactly what's required.
But right now, the sting of FDA's rejection will take its toll on Titan's valuation given the uncertainty about the timing and cost of a Probuphine resubmission. The company has about $18 million in cash on hand, equivalent to 22 cents per share.
Investors were hoping FDA would approve Probuphine based on the generally positive recommendation favoring the new opioid dependence therapy made by an advisory panel in March. At worst, the FDA was expected to delay an approval decision so that the agency and Titan could complete work on a risk management plan to insure safe implantation and use Probuphine -- a series of small rods containing the drug buprenorphine that is implanted just under the skin of addicts and slowly releases the drug over six months.
Instead, FDA said it could not approve Probuphine until Titan comes back with new clinical data demonstrating the device's efficacy at additional dose levels, including the higher doses that more closely approximate blood levels of sublingual buprenorphine more commonly used today to treat opioid addicts.
This FDA request appears to come in direct response to concerns raised at the March FDA panel by an addiction expert who criticized Titan for not providing information to guide doctors on the number of Probuphine rods to implant in opioid addicts who were stabilized on oral buprenorphine.
The FDA also asked Titan to provide additional information on the training necessary to implant and remove Probuphine. Again, experts at the March advisory panel raised concerns about the level of training necessary to safely use Probuphine in patients.
-- Reported by Adam Feuerstein in Boston.