Lipocine Inc Halted: Feds Eye Safety, Efficacy Of Testosterone

Lipocine Inc LPCN shares were halted for trading while a meeting of federal regulators proceeded Wednesday probing the safety and efficacy of testosterone therapy.

Lipocine's two lead drug candidates are oral testosterone replacement therapies with marketing approval requests expected in coming quarters.

Heavy advertising by various companies targeted to older men suggest that fatigue, reduced sex-drive and weight gains can be ameliorated by dosing with testosterone, but federal regulators call the evidence "questionable."

Testosterone prescriptions grew to 2.3 million patients in 2013 from about one million in 2010, according to the Food and Drug Administration. A quarter of those patients were never tested for testosterone levels, despite receiving therapy.

Two recent studies suggest that testosterone therapy carries significant heart attack risks, although the FDA said the studies were too small to use for conclusions and are contradicted by other evidence.

Testosterone has been approved for marketing in the U.S. for about 50 years.

In a move announced in July, the FDA convened a joint meeting Wednesday to discuss testosterone including its Drug Safety and Risk Management Advisory Committee and its Bone, Reproductive and Urologic Drugs Committee.

Leading current suppliers of testosterone inclue AbbVie Inc., Auxilium Pharmaceuticals, Inc., Eli Lilly and Co. and Endo International PLC.