FDA Refuses to File Letter for Adamis’ Cialis Alternative

Shares of Adamis Pharmaceuticals are down nearly 5 percent this morning after the company announced late Tuesday that the U.S. Food and Drug Administration (FDA)rejected its sublingual tadalafil product for erectile dysfunction, an alternative to the blockbuster Cialis.

San Diego-based Adamis said it received a Refusal to File letter from the regulatory agency regarding its New Drug Application for the treatment. According to a statement from the company, the FDA determined that the NDA was not sufficiently complete in order to review the treatment for potential approval. The FDA asked the company to include in a resubmitted NDA additional information regarding “longer real-time (versus accelerated) stability data and additional dissolution data for both the clinical and registration batches.” In its announcement Tuesday, Adamis said it may seek guidance from the FDA, which could include the request of a Type A meeting to discuss the contents of the letter and determine the most appropriate path forward for a resubmitted NDA.

Adamis is a specialty biopharmaceutical company that seeks to develop lower-cost solutions for patients in two primary therapeutic areas, respiratory disease and allergies.

Tadalafil, which is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors, is used to treating erectile dysfunction, pulmonary hypertension and benign prostatic hyperplasia. Tadalafil is the active ingredient in Eli Lilly’s erectile dysfunction drug, Cialis. Pfizer’s Viagra and GlaxoSmithKline’s Levitra use sildenafil and vardenafil, respectively, which are oral drugs that are also PDE5 inhibitors.

Source – Adamis regulations

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