FDA Action Alert: Sol-Gel, Eton and Pacira


The U.S. Food and Drug Administration (FDA) is starting off August with a mix of PDUFA dates for acne products, seizure medications and a new manufacturing process for a non-opioid pain killer. Here’s a look.

Sol-Gel’s Twyneo for Acne

Sol-Gel Technologies, headquartered in Ness Ziona, Israel, had a target action date of August 1, 2021, for its New Drug Application (NDA) for Twyneo (benzoyl peroxide, 3%, and tretinoin, 0.1%, cream). On July 27, the FDA approved the product. It is the first FDA-approved treatment for acne that contains a fixed-dose combination of benzoyl peroxide and tretinoin. As part of its preparation for a U.S. launch, the company opened U.S. headquarters in Whippany, New Jersey.

Both tretinoin and benzoyl peroxide are commonly prescribed individually as a combination treatment for acne. Benzoyl peroxide degrades the tretinoin molecule, which potentially decreases its effectiveness if used simultaneously or combined in the same formulation. The company’s silica-based microcapsule is engineered to prevent tretinoin from being oxidated by benzoyl peroxide, which improves the stability of the two ingredients. The shell is also built to release the ingredients gradually over time.

“The FDA approval of Twyneao underscores our ability to deliver innovative, proprietary drugs to the market,” said Alon Seri-Levy, co-founder and chief executive officer of Sol-Gel. “Based on the clinical data observed, we believe that Twyneo has the potential to change the treatment landscape for the tens of millions of patients suffering from acne vulgaris. With market leader, Galderma, handling the product launch of Twyneo, we are excited that Twyneo will soon be able to patients in the U.S.”

Eton’s Topiramate for Seizures and Migraine

Eton Pharmaceuticals, based in Deer Park, Illinois, has a target action date of August 6 for its NDA for topiramate oral solution, which was submitted for three indications: monotherapy for partial-onset or primary general tonic-clonic seizures in patients two years and older; adjunctive therapy for partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years and older; and as preventative treatment of migraine in people 12 years of age and older.

In October 2020, when the FDA accepted the NDA, Sean Brynjelsen, chief executive officer of Eton, said, “Topiramate is one of the most widely compounded oral liquids, and our product addresses the unmet need for pediatric-friendly formulations of the molecule. We look forward to working with the FDA to bring a safe, effective, FDA-approved product to patients and caregivers as quickly as possible.”

Pacira BioSci’s New Manufacturing Process for Exparel

Pacira Biosciences, located in Parsippany, New Jersey, has a target action date of August 6 for its supplemental New Drug Application (sNDA) for its new manufacturing process for Exparel (bupivacaine liposome injectable suspension). Exparel is indicated for single-dose infiltration in adults for local analgesia after surgery and as an interscalene brachial plexus nerve block for postsurgical regional analgesia. In August 2020, the FDA accepted the sNDA for expansion of the drug to include children aged six and over, with a target action date of March 22, 2021. On March 22, the FDA approved Exparel for children.

On May 18, 2021, Pacira announced that the U.S. Patent and Trademark Office (USPTO) had issued a Notice of Allowance for the patent related to Exparel’s new manufacturing process.

“This new patent marks the first deliverable from our comprehensive patent strategy and adds yet another layer of market exclusivity that extends our proprietary position for Exparel into the 2040s,” said Dave Stack, chairman and chief executive officer of Pacira. “The comprehensives nature of the allowed claims underscores the deep multivesicular liposome manufacturing expertise that Pacira has accumulated over more than 25 years. Over the last six years, we have invested more than $100 million to create, design and commercialize a more efficient method for making Exparel, exceeding the U.S. Food and Drug Administration’s rigorous standards for safety and bioequivalence. Our innovative manufacturing processes for Exparel are a core competency that we are committed to safeguarding globally.”

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