Tuesday, July 24, 2018
Adamis Pharmaceuticals Corporation announced today that it has been conducting pre-IND development work for a fast-dissolving sublingual tablet containing tadalafil. Adamis intends to submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) with the goal of filing a New Drug Application (NDA) before year end.
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.
Adamis’ first goal in development and clinical testing will be to demonstrate comparability to Cialis® and additional benefits of a rapidly acting sublingual formulation.
Dr. Dennis J. Carlo, President and CEO of Adamis, stated, “The theme throughout our expanding pipeline is to develop improved methods of delivering well-established drugs to compete within large, well-established markets. If we are able to achieve stated clinical objectives and our product is eventually approved, I feel there would be demand for our sublingual tadalafil product within the multibillion dollar ED market. We have developed a product and a clinical plan with the objectives of filing an IND and submitting an NDA before year end. Additionally, we continue to work on our naloxone product with the objective of filing an NDA before year end.”
