FDA News

FDA accepts NDAs for oral IV Solithera

The FDA has accepted two new drug applications for the oral and IV formulations of Solithera, according to a press release from the drug’s manufacturer.

Solithera (solithromycin, Cempra) is a novel next-generation macrolide intended to treat community-acquired bacterial pneumonia (CABP). The treatment has shown potent activity against macrolide-resistant strains of pneumonia, with in vitro and in vivo studies suggesting efficacy against other pathogens including community-acquired MRSA, streptococci, haemophilus, enterococci and Mycobacterium avium, according to the release.

Prabhavathi Fernandes, PhD

Prabhavathi Fernandes

“The FDA’s acceptance of our two NDA filings brings us one step closer to the potential approval by the end of 2016 and U.S. commercial launch of Solithera,” Prabhavathi Fernandes, PhD, president and CEO of Cempra, said in the release. “If approved, Solithera would be a significant milestone in the treatment of CABP, as bacterial resistance to older treatments has continued to rise.”

The acceptance was based on favorable results from two phase 3 trials reported within the past year, according to the release. The first of these, SOLITAIRE-Oral, demonstrated oral solithromycin’s noninferiority to moxifloxacin therapy among patients with identified Mycoplasma pneumoniae infection (early clinical response absolute difference, 0.29%; 95% CI, –5.5 to 6.1). More recently, SOLITAIRE-IV demonstrated similar outcomes between IV-to-oral solithromycin and moxifloxacin regimens (early clinical response absolute difference, – 0.46; 95% CI, –6.1 to 5.2), regardless of macrolide resistance.

Brian D. Jamieson, MD

Brian D. Jamieson

“For [community-acquired pneumonia (CAP)], there really haven’t been any new oral drugs for use in the community — telithromycin and moxifloxacin were really the only two in the last 15 years, but neither of these were useful in pediatric populations,” Brian D. Jamieson, MD, senior director of clinical research at Cempra, told Infectious Disease News. “[Solithromycin would] be the first new antibiotic for CAP in about 25 years that will have pediatric suspension, IV and oral formulations.”


Barrera CM, et al. Lancet. 2016;doi:10.1016/S1473-3099(16)00017-7.

Sheets A, et al. Abstract Saturday-467. Presented at: ASM Microbe; June 16-20, 2016; Boston.

Disclosures: Fernandes and Jamieson are employees of Cempra.