FDA Action Alert: Foamix, Eton, Adamis and RedHill

FDA Action

We round out the month of October and start the month of November with four PDUFA dates on the U.S. Food and Drug Administration (FDA)’s calendar. Here’s a look.

Foamix Pharmaceuticals FMX103 for Acne

Foamix Pharmaceuticals has a target action date of October 20 for its FMX101 to treat inflammatory lesions of non-nodular moderate-to-severe acne vulgaris. The drug’s New Drug Application (NDA), as FMX103 (minocycline topical foam 1.5%) for moderate-to-severe papulopustular rosacea in adults, has also been submitted and was accepted on October 17. The second application has a target action date of June 2, 2020.

On Friday, October 13, the FDA approved the NDA for FMX101.

FMX101 (4% minocycline foam) is a tetracycline-class antibiotic. The company’s technology platform is called the Molecule Stabilizing Technology (MST) that reengineers topical treatments. Tetracyclines are the most common treatment for acne, but they’re only available in oral dosages. Foamix’s tech platform results in topical tetracyclines.

Eton Pharmaceuticals’ ET-202 Ready-to-Use Phenylephrine

Eton Pharmaceuticals has a target action date of October 21 for its ET-202, its ready-to-use hospital formulation of phenylephrine. Phenylephrine is a decongestant, but for hospital use as an injectable, is used to treat hypotension (low blood pressure) that might occur during surgery. Phenylephrine injectable is only available in concentrated versions that require dilution prior to administration. Hospitals typically purchase non-FDA approved ready-to-use products from compounding laboratories or manually dilute them in-house. ET-202 is a ready-to-use formulation that would not require dilution.

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Adamis Pharmaceuticals’ Zimhi for Opioid Overdose

Adamis Pharmaceuticals has a target action date of October 31 for its Zimhi (naloxone) injection to treat opioid overdoses. Zimhi is a naloxone injection to treat opioid overdose. It utilizes the Symject syringe drug delivery system used in the company’s approved Symjepi product for emergency treatment of allergic reactions.

In June, Adamis amended its New Drug Application (NDA) for Zimhi, removing any reference to Kaleo’s Evzio and withdrawing a Paragraph IV certification related to that product. Then, on August 8, the company indicated it was running additional pharmacokinetic (PK) studies comparing Zimhi and a relevant comparator. That PK data was recorded and forwarded in September to the FDA. The PDUFA date remained October 31.

RedHill Biopharma’s Talicia for H. pylori Infection

RedHill Biopharma has a target action date of November 2 for its Talicia (RHB-105) for H. pylori infection. It was approved under Priority Review designation. H. pylori bacterial infection affects about half of the global population and about 35% of the U.S. population. It is classified as a Group I carcinogen and is the strongest risk factor for the development of gastric cancer and a major risk factor for peptic ulcer disease and gastric mucosa-associated lymphoid tissue (MALT) lymphoma.

Talicia is a novel and proprietary fixed-dose, all-in-one oral capsule combination of two antibiotics, rifabutin and amoxicillin, and a proton pump inhibitor (PPI), omeprazole. It is designed to deal with increasing antibiotic resistance of H. pylori.

The NDA was built on the results from two successful Phase III trials in the U.S. The ERADICATE Hp2 confirmatory Phase III trial hit its primary endpoint, showing 84% eradication of H. pylori infection from the drug. The ERADICATE Hp first Phase III study also hit its primary endpoint, showing 89.4% efficacy in eradicating H. pylori infection.

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