Solithromycin is a macrolide antibiotic that has undergone review for the treatment of community-acquired bacterial pneumonia. Solithromycin is also being investigated and has shown promise for the treatment of gonorrhea. With increasing antibiotic resistance, the development of novel antibiotics to combat infections is essential. The unique ribosome-binding stability of solithromycin and mild side effect profile make this a promising new antibiotic. This article will provide an overview on the mechanism of action, clinical efficacy, and safety of this drug for the treatment of gonorrhea. Relevant data were identified through a comprehensive literature search using multiple databases using the keywords solithromycin, CEM-101, and gonorrhea.
FileTMJrRewerskaBVucinic-MihailovicV. SOLITAIRE-IV Pneumonia Team. Double-blind, multicenter study comparing the efficacy and safety of intravenous-to-oral solithromycin to intravenous-to-oral moxifloxacin for treatment of community-acquired bacterial pneumonia. Clin Infect Dis. 2016;63(8):1007–1016.
2.
Cempra [Internet]. Cempra Receives Complete Response Letter from FDA for Solithromycin NDAs. Chapel Hill, NC: Cempra Pharmaceuticals. http://investor.cempra.com/. Published 2016. Updated December 29, 2016. Accessed March 28, 2017.
3.
MandellLAWunderinkRGAnzuetoA; Infectious Diseases Society of America; American Thoracic Society. Infectious Diseases Society of America/American Thoracic Society consensus guidelines management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27–S72.
4.
Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2015. MMWR Morbid Mortal Wkly Rep. 2015;63(3):60–68.
5.
World Health Organization (WHO). Global Incidence and Prevalence of Selected Curable Sexually Transmitted Infections—2008. Geneva, Switzerland: World Health Organization; 2012:2012.
6.
Centers for Disease Control and Prevention (CDC) [Internet]. Antibiotic-Resistant Gonorrhea Basic Information. Atlanta, GA: Centers for Disease Control and Prevention (CDC). http://www.cdc.gov/std/gonorrhea/arg/basic.htm. Published 2013. Updated June 13, 2016. Accessed September 3, 2016.
7.
GolparianDFernandesPOhnishiMJensenJSUnemoM. In vitro activity of the new fluoroketolide solithromycin (CEM-101) against a large collection of clinical Neisseria gonorrhoeae isolates and international reference strains, including those with high-level antimicrobial resistance: potential treatment option for gonorrhea?Antimicrob Agents Chemother. 2012;56(5):2739–2742.
8.
Van BambekeFTulkensPM. The role of solithromycin in the management of bacterial community-acquired pneumonia. Expert Rev Anti Infect Ther. 2016;14(3):311–324.
9.
MallegolJFernandesPSeahCGuyardCMelanoRG. Determination of in vitro activities of solithromycin at different pHs and its intracellular activity against clinical isolates of Neisseria gonorrhoeae from a laboratory collection. Antimicrob Agents Chemother. 2013;57(9):4322–4328.
10.
HookEWIIIGoldenMJamiesonBD. A phase 2 trial of oral solithromycin 1200 mg or 1000 mg as single-dose oral therapy for uncomplicated gonorrhea. Clin Infect Dis. 2015;61(7):1043–1048.
11.
ClinicalTrials.gov [Internet]. Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea (SOLITAIRE-U): NCT02210325. Bethesda, MD: U.S. National Institutes of Health. http://clinicaltrials.gov/ct2/show/record/NCT02210325. Published 2014. Updated September 20, 2016. Accessed August 29, 2016.
12.
Llano-SoteloBDunkleJKlepackiD. Binding and action of CEM-101, a new fluoroketolide antibiotic that inhibits protein synthesis. Antimicrob Agents Chemother. 2010;54(12):4961–4970.
BertrandDBertrandSNeveuEFernandesP. Molecular characterization of off-target activities of telithromycin: a potential role for nicotinic acetylcholine receptors. Antimicrob Agents Chemother. 2010;54(12):5399–5402.
15.
PutnamSDSaderHSFarrellDJBiedenbachDJCastanheiraM. Antimicrobial characterization of solithromycin (CEM-101), a novel fluoroketolide: activity against staphylococci and enterococci. Int J Antimicrob Agents. 2011;37(1):39–45.
16.
PutnamSDCastanheriaMMoetGJFarrellDJJonesRN. CEM-101, a novel fluoroketolide: antimicrobial activity against a diverse collection of Gram-positive and Gram-negative bacteria. Diagn Microbiol Infect Dis. 2010;66(4):393–401.
17.
StillGJSchranzJDegenhardtTP. Pharmacokinetics of solithromycin (CEM-101) after single or multiple oral doses and effects of food on single-dose bioavailability in healthy adult subjects. Antimicrob Agents Chemother. 2011;55(5):1997–2003.
18.
JamiesonBDCiricSFernandesP. Safety and pharmacokinetics of solithromycin in subjects with hepatic impairment. Antimicrob Agents Chemother. 2015;59(8):4379–4386.
19.
U.S. Food and Drug Administration (FDA). Solithromycin for the treatment of community acquired bacterial pneumonia; Briefing document for the antimicrobial drugs advisory committee, Meeting Date; November 4, 2016. Chapel Hill, NC: Cempra Pharmaceuticals Inc; 2016:173.
20.
JensenJAFernandesPUnemoM. In vitro activity of the new fluoroketolide solithromycin (CEM-101) against macrolide-resistant and susceptible Mycoplasma genitalium strains. Antimicrob Agents Chemother. 2014;58(6):3151–3156.
21.
RoblinPMKohlhoffSAParkerCHammerschlagMR. In vitro activity of CEM-101, a new fluoroketolide antibiotic, against Chlamydia trachomatis and Chlamydia (Chlamydophila) pneumoniae. Antimicrob Agents Chemother. 2010;54(3):1358–1359.
22.
FigueiraMFernandesPPeltonSI. Efficacy of solithromycin (CEM-101) for experimental otitis media caused by nontypeable Haemophilus influenza and Streptococcus pneumonia. Antimicrob Agents Chemother. 2016;60(9):5533–5538.
23.
KeelanJAPayneMSKempMWIrelandDJNewnhamJP. A new, potent, and placenta-permeable macrolide antibiotic, solithromycin, for the prevention and treatment of bacterial infections in pregnancy. Front Immunol. 2016;7(111):1–11.
