FDA Approves Delafloxacin for Bacterial Skin Infection Treatment

The US Food and Drug Administration has approved Melinta Therapeutics’ delafloxacin (Baxdela), a new antibacterial drug to treat acute bacterial skin and skin structure infections.

The drug is available for intravenous and oral use, according to an agency statement. The most common adverse reactions were nausea, diarrhea, headache, transaminase elevations, and vomiting.

Like all fluoroquinolones, delafloxacin has a Boxed Warning to alert health care professionals and patients that it can increase risk of “disabling and potentially irreversible serious adverse reactions that have occurred together including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects.”

Delafloxacin is contraindicated for patients with known hypersensitivity to fluoroquinolones.

In contrast to most FDA-approved fluoroquinolones, which are zwitterionic, delafloxacin has an anionic character. This results in a 10-fold increase in delafloxacin accumulation in both bacteria and cells at acidic pH, which is believed to give the drug an advantage for the eradication of some bacteria in acidic environments.

The drug received the FDA’s fast track designation — a process designed to facilitate the development and expedite the review of drugs to treat serious conditions that fill an unmet medical need.

“The purpose is to get important new drugs to the patient earlier,” according to the FDA.

It was also given priority review status, which sped the review process from 10 months to 6 months.