Lipocine Inc. (NASDAQ: LPCN) may be down but it is not out. The company plans to meet FDA with hopes of getting clear understanding of why the agency refused to approve its testosterone replacement drug LPCN 1021. At the meeting with the FDA, LPCN is also hoping to agree on the path it needs to take with the drug candidate to achieve regulatory clearance for marketing in the U.S.
The FDA issued Lipocine Inc. (NASDAQ: LPCN) with a complete response letter (CRL) relating to its application for commercialization of LPCN 1021. CRL is a polite way that FDA tells companies that it cannot approve their drugs for marketing in the present form of their application. But the FDA is usually kind enough to tell companies whose drugs it has declined to approve where the issues lie and what they might need to do to get its approval.
In the case of LPCN 1021, the agency pointed out deficiencies relating to the dosing of the medicine. Specifically, the FDA found that the titration scheme used in the Phase 3 study of LPCN 1021 differed from the proposed titration for real-world clinical practice.
Oral testosterone drug
Lipocine Inc. (NASDAQ: LPCN) is developing LPCN 1021 as an oral testosterone replacement for use in adult males. Deficiency of testosterone leads to a number of effects in the body of a male person such as loss of libido, fatigue and depression can also set in.
According to Lipocine, its oral LPCN 1021 provides a better way to deal with testosterone shortage compared to injectable and topical therapies. That is another reason CEO of Lipocine Inc. (NASDAQ: LPCN), Mahesh Patel, said that they will work closely with FDA to see that the drug gets approved.
Evaluating the FDA’s letter to Lipocine Inc. (NASDAQ: LPCN)
In the meantime, Patel said that they are evaluating the content of the letter from the FDA. Their evaluation includes looking into details on what led to the rejection and the recommendations that the regulator provided.