- Salt Lake City-based specialty pharma Lipocine announced Monday it has completed a post-action meeting with the Food and Drug Administration, clearing a path forward for its testosterone-replacement therapy after a regulatory setback over the summer.
- In June, Lipocine received a complete response letter from the FDA flagging problems with the dosing algorithm for the label of its oral testosterone product, LPCN 1021. Shares tumbled on the news, falling in value by more than half immediately afterwards.
- In response to the FDA's critique, Lipocine submitted a new dosing validation study protocol, which the regulator has agreed to review under a special protocol assessment. If the SPA is approved, Lipocine would need to carry out the validation study in order to secure a review.
Depressed? Shrinking muscles and expanding waistline? Tired? Millions of men across America with these symptoms have followed the advice of the direct-to-consumer (DTC) ads and asked for testosterone therapy.
In 2016, half a million prescriptions a month were written for testosterone replacement therapy, according to IMS Health figures cited by Lipocine. Drug Watch has predicted sales of $5 billion for the market by 2017, a marked jump from $2 billion in 2012.
However, prescribing testosterone isn't without concerns. In March 2015, responding to worries about heart risk and over-prescribing, the FDA changed the labeling for testosterone products to warn people of the risk. The new warnings included an advisory that testosterone treatment is only approved for low testosterone with a known cause, including disorders of the testicles, pituitary gland or brain.
With LPCN-1021, Lipocine is hoping to meet an unmet need for hypogonadism, which is currently treated with short-acting injectable and topical products.
Lipocine also has other products in its pipeline: LPCN 1111, a testosterone prodrug in Phase 2, and LPCN 1107, a hydroxyprogesterone to prevent recurrent preterm birth in Phase 2 testing.
Other drugmakers are trying to break into the market, as well. Repros Therapeutics' oral small molecule enclomiphene will face an FDA advisory committee in December 2016 to discuss clinical trial design for secondary hypogonadism (low testosterone).