Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that it has received a Refusal to File letter from the United States Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for its sublingual Tadalafil powder product. As previously announced, on December 28th, 2018, Adamis submitted an NDA for fast-disintegrating sublingual tadalafil (APC-8000) with the FDA for the treatment of erectile dysfunction (ED).
Upon its preliminary review, the FDA determined that the submitted NDA was not sufficiently complete to permit a substantive review. The FDA requested that Adamis supplement and include in a resubmitted NDA (i) longer real-time (versus accelerated) stability data and (ii) additional dissolution data for both the clinical and registration batches. Adamis may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter with the agency and seek additional guidance concerning information, data and specific deliverables that the agency would require for a resubmitted NDA to be deemed complete.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “We are obviously very disappointed with this development and are evaluating the letter and what the FDA has requested. We intend to work closely with the FDA to try to clearly map the path forward.”
Tadalafil is a drug used for treating erectile dysfunction (ED), pulmonary hypertension and benign prostatic hyperplasia (BPH). Tadalafil is in a class of drugs called phosphodiesterase-5 (PDE5) inhibitors which includes, among others, sildenafil and vardenafil. Tadalafil is the drug in Lilly’s Cialis®, sildenafil is the drug in Viagra® (Pfizer) and vardenafil is the drug in Levitra® (GlaxoSmithKline). All three drugs of these oral tablets are FDA approved and clinically indicated for the treatment of ED.