Taksta noninferior to Zyvox in treating skin infections

Taksta oral tablets were noninferior to Zyvox in treating skin infections such as MRSA in a recent phase 3 clinical trial, the experimental drug’s manufacturer announced.

Taksta (fusidic acid, Cempra) was also well-tolerated in the trial involving 716 patients with acute bacterial skin and skin structure infections (ABSSSIs).

“Considering complicated skin infections are one of the most rapidly growing reasons for hospitalizations and emergency department visits each year, the results with fusidic acid in this study are promising, especially for an outpatient population where there is a need for new oral drugs that are effective against MRSA,” William O’Riordan, MD, CEO of eStudySite, said in a news release.

The patients at 62 sites in the United States were randomized to receive either fusidic acid (n = 359) or oral Zyvox (linezolid, Pfizer, n = 357) every 12 hours for 10 days.

In all, 67.5% of the patients had infections associated with IV drug use, and less than 5% had received antibiotics before the trial.

Just over 87% of patients receiving fusidic acid (n = 313) met the study’s primary endpoint of survival with a 20% or greater reduction in lesion size at 48 to 72 hours after the start of treatment without the use of rescue antibiotics vs. 86.6% (n = 309) of patients receiving linezolid.

Of the patients with available information, 95.7% receiving fusidic acid (n = 292/305) achieved clinical success 7 to 14 days after the end of treatment, as compared to 96.9% (n = 283/292) of those who received linezolid.

All fusidic acid recipients who had MRSA (n = 99) achieved success at the 7- to 14-day mark.

Patients receiving fusidic acid experienced treatment-emergent adverse effects at a rate of 37.9% compared to 36.1% of those receiving linezolid. Of the 14 total serious adverse events recorded, one in the fusidic acid group (vomiting) was considered study drug-related, as were two in the linezolid group (one drug-induced liver injury and one case of vomiting).

Cempra representatives said they will present all of the study data at a future scientific forum.

“We are excited that the results of this phase 3 study with fusidic acid confirm the results of our phase 2 study and are consistent with the more than 40 years of experience that the product has accumulated outside the United States,” David Oldach, MD, CEO of Cempra, said in the release.

“We look forward to meeting with the FDA to discuss the next steps required to bring fusidic acid to patients in the United States.” – by Joe Green

Disclosures: Oldach is an employee of Cempra and O’Riordan is an employee of eStudySite.