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FDA Rejects Xyosted for Hypogonadism
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FDA sends response letter for deficiencies found in Antares Pharma’s QuickShot Testosterone auto injector.
The US Food and Drug Administration (FDA) has rejected the QuickShot Testosterone (XYOSTED) for the treatment of low testosterone levels associated with hypogonadism in adult males, announced Antares Pharma.
Antares Pharma received a response letter from the FDA regarding the New Drug Application (NDA) indicating that the FDA cannot approve XYOSTED in its present form.
The letter identified 2 deficiencies related to clinical data based on findings in studies QST-13-003 and QST-15-005.
The FDA expressed concern that XYOSTED could cause a meaningful increase in blood pressure, as well as questioned the occurrence of depression and suicidality. No Chemistry, Manufacturing and Controls (CMC), device or efficacy issues were noted in the letter.
On Oct. 12, Antares Pharma announced it received notice from the FDA which identified unnamed deficiencies preventing the drug from moving forward in the labeling and postmarketing requirements process. In the letter, the FDA did not specify the deficiencies.
The drug-device combination product delivers testosterone enanthate using a subcutaneous auto injector for adult males with low testosterone associated with hypogonadism. XYOSTED is being designed an at home, weekly, self-administered testosterone replacement option.
XYOSTED is designed to allow the rapid subcutaneous self-administration of highly viscous drugs like testosterone and biologics using a high spring pressure through a fine gauge needle. Phase 3 data showed that testosterone delivered provided rapid, steady and reliable efficacy by restoring testosterone to pre-defined physiologic levels.
Hypogonadism is the most common male endocrine problem and due to an aging population, the incidence rate is expected to rise, becoming a disease that warrants further attention. Current treatment is testosterone replacement therapy (TRT).
The next step is for Antares Pharma to request a meeting with the FDA to further evaluate the deficiencies.
A press release has been made available.
