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Melinta submits two NDAs for novel antibiotic to treat ABSSSI

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NEW ORLEANS — Melinta Therapeutics announced this week that it has submitted two New Drug Applications, or NDAs, to the FDA for the approval of IV and oral Baxdela for the treatment of acute bacterial skin and skin structure infections, or ABSSSIs.

Baxdela (delafloxacin) is a novel anionic fluoroquinolone being developed to treat both gram-negative and gram-positive organisms, including MRSA, according to John Temperato, COO of Melinta.

The FDA designated delafloxacin as a Qualified Infectious Disease Product (QIDP), expediting the review process. Temperato said the company expects a regulatory decision by June 2017 and would launch the drug within 8 to 10 weeks if the NDAs are approved.

“We plan to commercialize it ourselves, building a focused hospital sales force,” Temperato said in an interview at IDWeek 2016. “We’re really mindful of appropriate utilization.”

Melinta said the NDAs were based on two phase 3 studies that compared the drug with a combination regimen of vancomycin and aztreonam.

In the studies, delafloxacin was noninferior to vancomycin plus aztreonam in reducing lesion size at the primary infection site by at least 20% at 48 to 72 hours, according a company press release.

The trials also found that delafloxacin was well-tolerated among patients regardless of age or gender, with less than 1% discontinuing treatment because of adverse effects, the company said.

In addition, delafloxacin is being assessed for the treatment of urinary tract infections, and the FDA has granted the drug fast track designation for the treatment of community-acquired bacterial pneumonia. It is the subject of six poster presentations at IDWeek.

“From a provider standpoint, it’s about optionality,” Temperato said. “We’re very mindful of stewardship and appropriate utilization. We think the opportunity that a provider has with Baxdela is to simplify their algorithm, so we’re not asking someone to use a fluoroquinolone for bronchitis or sinusitis, but appropriately used for the right skin patient, it makes a lot of sense.” – by Gerard Gallagher

Disclosures: Temperato is employed by Melinta Therapeutics.