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FDA issues complete response letter for new oral testosterone formulation
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The FDA has issued a complete response letter regarding a new drug application for an oral formulation of testosterone undecanoate, according to a press release from Lipocine.
The oral testosterone formulation (Tlando) is designed to help restore normal testosterone levels in men with hypogonadism, according to the company.
The FDA issues a complete response letter to an applicant if the agency determines that it will not approve the application or abbreviated application in its present form for one or more reasons.
“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,” Mahesh Patel, PhD, chairman, president and CEO of Lipocine, said in the release.
The complete response letter identified one deficiency, stating the efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations, according to Lipocine. The letter did not identify specific issues relating to the chemistry, manufacturing or controls of the drug.
The complete response letter follows the approval of another oral testosterone formulation in March. As Endocrine Today previously reported, the FDA approved oral testosterone undecanoate (Jatenzo, Clarus Therapeutics), making it the first new oral testosterone replacement product in more than 60 years. The indication is for men with low testosterone levels due to specific medical conditions, such as Klinefelter syndrome or tumors that have damaged the pituitary gland. Other available options for men approved by the FDA in the last 5 years include a once-weekly, single-use autoinjector of testosterone enanthate for men with primary or hypogonadotropic hypogonadism (Xyosted, Antares Pharma Inc.), approved in October 2018, and an intranasal testosterone gel (Natesto, Aytu BioScience) for men with congenital or acquired hypogonadism, approved in 2014. – by Regina Schaffer
Disclosure: Patel is chairman, president and CEO of Lipocine.