FDA Cites Secondary Efficacy Endpoints Not Met
Lipocine said Monday the FDA said "nay" for the third time for its Tlando, an oral testosterone replacement therapy for use in adult males for treating conditions associated with hypogonadism, which is a deficiency of endogenous testosterone.
The complete response letter, or CRL, issued by the FDA signaling the application cannot be approved in the present form, pointed to one deficiency — the efficacy trial not meeting the three secondary endpoints for maximal testosterone concentration. The CRL, however, did not identify issues related to chemistry, manufacturing and controls.
Third Time Unlucky
Lipocine initially submitted the NDA for Tlando back in 2015, although the FDA shot down the application the very next year on the grounds that there were deficiencies related to the dosing algorithm for the label.
The company resubmitted the application a little over a year later in 2017. This time around, the company had to face FDA's Bone, Reproductive and Urologic Drugs Advisory Committee in January 2018. The FDA panel voted 6 to 13, recommending rejection of the drug following which the regulatory body rejected the application yet again, citing four deficiencies.
Following the second resubmission and the acceptance of the application, the FDA had set a PDUFA action goal date of Nov. 9.
Lipocine expressed disappointment at the FDA rejection, which is understandable, given Tlando is the most advanced drug candidate in its pipeline.
"We are disappointed by the FDA's decision and intend to request a meeting with the FDA as soon as possible to discuss a potential path forward for the approval of TLANDO," said Dr. Mahesh Patel, CEO of Lipocine.
Lipocine shares were tumbling 77% to 62 cents, after trading in a 52-week range of $1.04-$3.54.