FDA Issues Refusal to File Letter for Adamis' Alternative to Cialis

Man holding gavel and giving thumbs down sign

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.

“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,” Dennis J. Carlo, president and chief executive officer of Adamis, said in a statement.

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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.

Adamis does have an approved treatment on the market. Its product Symjepi is an epinephrine injection pre-filled syringe product for use in the emergency treatment of anaphylaxis, which is a competitor to Mylan’s EpiPen. Last year, Adamis sold the U.S. commercial rights to Symjepi to Swiss pharma giant Novartis. Under terms of that deal, net profits in the U.S. will be shared equally by Adamis and Sandoz, a division of Novartis. Sandoz launched Symjepi in January.

With the rising costs of healthcare in recent years, Adamis has been focusing on creating low-cost therapeutic alternatives in large markets in order to grow its business and to make treatments more affordable for more people. Adamis is also currently developing other specialty pharmaceutical product candidates including APC-1000, an HFA inhaled nasal steroid product for the potential treatment of asthma, APC-6000, a naloxone injection for the potential treatment of opioid overdose and APC-4000, fluticasone with a DPI propellant for the potential treatment of asthma. Days after the company filed its NDA for its erectile dysfunction drug, it also filed an NDA for its opioid-overdose treatment.

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