Lipocine Craters After FDA Rejects Testosterone Replacement Therapy Drug for the Second Time

Shares of Utah-based Lipocine, Inc. are down more than 41 percent in premarket trading after the company announced it received a second Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its testosterone replacement therapy product.

The FDA had previously rejected Lipocine’s Tlando in 2016 and the company resubmitted its New Drug Application last year following concerns over dosing algorithms. The latest CRL issued by the FDA was no surprise following the overwhelming rejection of an advisory committee earlier this year. In January the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee voted 13 to 6 against the benefit/risk profile for Tlando.

This morning Salt Lake City-based Lipocine said the latest CRO identified four deficiencies in the company’s New Drug Application for Tlando. Those deficiencies include determining the extent, if any, that ex vivo conversion of testosterone undecanoate to testosterone in serum blood collection tubes to confirm the reliability of T data. The company has been asked to obtain definitive evidence through an ambulatory blood pressure monitoring study whether or not Tlando causes a clinically meaningful increase in blood pressure in hypogonadal men. Another deficiency the company has been asked to address the reliability of Cmax data. Once that is done Lipocine has been tasked with providing justification for non-applicability of the agreed-upon and prespecified Cmax secondary endpoints for Tlando. The fourth identified deficiency is determining the appropriate stopping criteria that can “reproducibly and accurately identify those patients who should discontinue use of Tlando.”

The CRL also identified additional comments that are not considered approvability issues, the company said. What those additional comments are were not disclosed.

Mahesh Patel, president and chief executive officer of Lipocine, said the company is disappointed by the Complete Response Letter. He said the deficiencies identified in the CRL were within the company’s expectations following a Jan. 10 meeting with the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee.

"We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies. We remain committed to work with the FDA to bring Tlando to patients," Patel said in a statement.  

Now the company will have to request a meeting with the FDA to further evaluate the deficiencies raised and work on a plan that will allow the company to have a second shot on goal. 

Tlando is an oral testosterone candidate developed for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.

Shares of Lipocine have fallen to $0.73 cents per share after investors dumped the stock. Lipocine closed at $1.78 on Tuesday.