SAN DIEGO, CA, USA I February 26, 2019 I 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 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.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease and allergy. The company’s Symjepi (epinephrine) Injection 0.3mg and Symjepi (epinephrine) Injection 0.15 mg products were approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis previously announced a distribution and commercialization agreement with Sandoz, a division of Novartis Group, to market Symjepi in the U.S. Adamis is developing additional products, including a sublingual tadalafil product candidate for the treatment of erectile dysfunction, a naloxone injection product candidate for the treatment of opioid overdose, and a metered dose inhaler and dry powder inhaler product candidates for the treatment of asthma and COPD. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.
SOURCE: Adamis Pharmaceuticals
Post Views: 29
SAN DIEGO, CA, USA I February 26, 2019 I 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 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.
About Adamis Pharmaceuticals
Adamis Pharmaceuticals Corporation is a specialty biopharmaceutical company primarily focused on developing and commercializing products in various therapeutic areas, including respiratory disease and allergy. The company’s Symjepi (epinephrine) Injection 0.3mg and Symjepi (epinephrine) Injection 0.15 mg products were approved for use in the emergency treatment of acute allergic reactions, including anaphylaxis. Adamis previously announced a distribution and commercialization agreement with Sandoz, a division of Novartis Group, to market Symjepi in the U.S. Adamis is developing additional products, including a sublingual tadalafil product candidate for the treatment of erectile dysfunction, a naloxone injection product candidate for the treatment of opioid overdose, and a metered dose inhaler and dry powder inhaler product candidates for the treatment of asthma and COPD. The company’s subsidiary, U.S. Compounding, Inc., compounds sterile prescription drugs, and certain nonsterile drugs for human and veterinary use, to patients, physician clinics, hospitals, surgery centers and other clients throughout most of the United States.
SOURCE: Adamis Pharmaceuticals
Post Views: 29
