Monday, December 31, 2018
Adamis Pharmaceuticals Corporation today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its fast-dissolving sublingual tadalafil tablet. This product candidate is designed for the treatment of erectile dysfunction. Adamis submitted the NDA pursuant to Section 505(b)(2) of the Food, Drug & Cosmetic Act.
Tadalafil (Cialis®) 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 (Viagra®) and vardenafil (Levitra®). All three drugs of these oral tablets are FDA approved and clinically indicated for the treatment of ED. Tadalafil and sildenafil are also indicated for pulmonary hypertension, but among PDE5 drugs, only tadalafil is approved for the treatment of BPH.
Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis, stated, “The filing for the NDA for our tadalafil tablet represents an important milestone for our company. We are very pleased with the progress we have made with our tadalafil product candidate which we believe is well-positioned to compete in the large, multi-billion-dollar erectile dysfunction market. We look forward to working through the review process with the FDA and hope to bring this low-cost therapeutic alternative to the market.”
