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Melinta’s I.V., oral delafloxacin wins FDA nod in skin infections

By Randy Osborne, Staff Writer

Melinta Therapeutics Inc. won approval from the FDA for Baxdela (delafloxacin), in adults for the treatment of acute bacterial skin and skin structure infection (ABSSSI) caused by susceptible bacteria, and CEO Eugene Sun told BioWorld that the treatment will be made available as soon as possible.

“We don’t have a precise date, but early to mid-fall is what we are shooting for,” he said, noting that New Haven, Conn.-based Melinta must “fill the channel – distributors, retail, and pharmacies, all that,” a process that will take several weeks. The privately held company is “still debating” about how much to charge. “We’re going to try to be in the range of similar branded pharmaceuticals,” he said. “We know there is a lot of price and cost sensitivity and the healthcare system is stressed, so we want to be reasonable.” Melinta plans to be “very generous” with its patient-assistance program for those who have trouble making ends meet, he said.

Baxdela is a fluoroquinolone that exhibits activity against both gram-positive and gram-negative pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), and is available in both intravenous (I.V.) and oral formulations.

“There are a lot of agents for skin infections, and a fair number of agents that are active in MRSA, but MRSA and staph are not the only pathogens,” Sun said, whereas Baxdela goes after “pretty much all of the other bugs that could cause a serious skin infection, and we’ll have that in our label. People with serious underlying conditions diabetes, renal disease, obesity are at greater risk for those less common pathogens other than staph,” he said.

“It’s not an obesity story so much as a complicated-patient story,” Sun said. “A lot of diseases come with obesity, so patients tend to be on chronic medications. We studied patients with these conditions – we have over 50 percent of patients in the second phase III with high body mass,” many of whom also had “hepatitis, renal impairment, diabetes and so on,” he said.

In a patient with diabetes, or who’s had recent surgery, doctors “want to cover gram-positive and gram-negative bugs, so they’ll typically use vancomycin plus something else,” Sun said. “If you can use one drug [such as Baxdela] instead of two, then that saves a lot of hassle in terms of drug interactions, side effects, simplicity and so on. I would say it’s not one drug we are competing against. I think we present a pretty attractive, reasonable alternative in situations where other drugs are more difficult to use.”

Baxdela “turns out not to have very many drug interactions, in fact none at all, compared to other drugs,” Sun said. The two routes of administration make it easier to give. “There are a lot of antibiotics out there, good ones,” he added, but top-choice vancomycin, for example, is I.V.-only and often is combined with aztreonam. “The cost of a day in the hospital trumps everything,” he said, and this is “not just for economic reasons – the patients want to go home.” What’s more, “when you’re in the hospital, you’re surrounded by nasty germs,” and thus at risk for more trouble.

“The oral option is definitely is a biggie,” Sun said. Not only may it let patients leave the hospital sooner, but in some cases being admitted could be avoided. “Someone comes into the emergency room [and the doctor says to himself], ‘Well, the patient looks like they need broad-spectrum coverage, but they’re not that sick, I think I could get away with not hospitalizing them,’” as long as the patient makes a follow-up visit with the doctor after starting oral Baxdela.

“We had a pretty broad age range in our trials,” Sun said. “Our oldest patient was in the 90s.” The elderly tend to be physically smaller, not able to clear drugs as quickly, and generally less likely to rebound as younger patients do. “Call [age] a comorbidity if you want,” he said, but it’s more accurate to describe older patients as needing special consideration.

Baxdela won FDA clearance based on two phase III studies in patients with ABSSSI, showing that I.V. and oral monotherapy turned up statistically non-inferior to the combo of vancomycin plus aztreonam at the FDA primary endpoint of early clinical response at 48-72 hours. Baxdela was well tolerated, too, with a 0.9 percent discontinuation rate due to adverse events.