(Reuters) – The U.S. Food and Drug Administration on Monday declined to approve Lipocine Inc’s oral drug to treat a condition that results in lower production of male sex hormone for the third time, sending the drug developer’s shares down 34%.
The company said a letter from the regulator indicated the application could not be approved in its present form as Lipocine’s trial did not meet three secondary goals that were designed to assess if higher levels of testosterone in patients could raise safety concerns.
The decision marks the third regulatory setback in over three years for Lipocine’s Tlando, which aims to restore normal testosterone levels in men with deficiency or absence of testosterone.
The U.S. Census Bureau estimates that 21.7 million men in the United States aged between 30 and 79 may have low testosterone levels, a condition that could lead to a loss of libido, decreased muscle mass, fatigue and depression.
The FDA had first declined to approve Tlando in 2016 and then again in 2018, citing a dosing irregularity and asked for more data on whether the drug could cause a rise in blood pressure.
Through Tlando, Lipocine hopes to offer patients a safer alternative to topical treatments that could result in accidental transference of testosterone.
If approved, it will compete with an oral rival from Clarus Therapeutics that was approved in March.
The agency did not raise any specific issues relating to the Tlando’s chemical composition and its manufacturing, the company said, adding it intends to request a meeting with the FDA soon to determine a potential path forward for Tlando’s approval.
Shares of the Utah-based company fell 34% to $1.80 in premarket trading.
(Reporting by Trisha Roy, Tamara Mathias and Manojna Maddipatla in Bengaluru; Editing by Saumyadeb Chakrabarty and Shinjini Ganguli)