
KemPharm’s pain drug fails to get FDA committee backing for abuse-deterrent capabilities; shares plunge
pharmafile | May 6, 2016 | News story | Medical Communications, Sales and Marketing |
Shares in KemPharm (Nasdaq: KMPH) more than halved in pre-market trading after a US Food and Drug Administration advisory panel did not back abuse deterrent labelling for its trial pain drug.
The company’s trial abuse-deterrent product, Apadaz, to treat short-term management of acute pain, is currently being reviewed by the FDA. A final decision is set for June 9, 2016.
The FDA committee members voted 16 to 4 backing the approval of Apadaz as a pankiller. The panel, however, voted 18 to 2 recommending against labeling saying the drug was designed to prevent its abuse.
Chief Executive Travis Mickle said: “We continue to believe in the value of our prodrug technology as a platform for developing prescription opioids with abuse-deterrent properties. While it is inevitable that there will be different points of view when evaluating new molecular entities with abuse-deterrent properties, we will continue to work collaboratively with the FDA to complete the review process of Apadaz.”
The FDA is not bound to recommendations its committees make but generally follows them.
Trading in KemPharm stock was halted Thursday, prior to the FDA committee announcement.
Shares were down nearly 53% in pre-market trading.
Anjali Shukla






