FDA approves sarecycline for the treatment of moderate to severe acne

The US Food and Drug Administration (FDA) today approved sarecycline (Seysara, Almirall) for treating the inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.

Seysara™ is specifically designed antibiotic for dermatologic use in four decades. The drug has narrow -spectrum of activity explicitly targeting acne and rosacea specific pathogens (P. acnes, Staphylococcus aureus) and has limited activity against aerobic gram-negative gastrointestinal organisms compared to minocycline and doxycycline.

Its anti-inflammatory property is a plus to treat the inflammation associated with skin lesions of acne, and long half-life enables convenient once a day dosing.

The approval follows the encouraging results of two replicative, Phase III, randomized, multicenter, double-blind, placebo-controlled studies that compared sarecycline to placebo. Sarecycline was administered in the dose of 1.5 mg/kg/day for 12 weeks. The studies looked at nearly 2000 patients aged 9 years and above and found the drug to be significantly effective in bringing down the inflammation as early as 3 weeks of starting treatment.

"As dermatologists, we are always seeking ways to improve the management of our patients' disease. The results of the studies are encouraging, with statistically significant efficacy vs. placebo as early as 3 weeks. I am looking forward to having this as an option for my patients when it becomes available in 2019," Leon Kircik, MD, who participated in clinical trials for Seysara.

Allergan has U.S. rights to the development and commercialization of Seysara and has assigned such rights to Almirall SA, while Paratek retains all ex-U.S. rights.

Common side effects noted were nausea, headache, and nasopharyngitis, but the discontinuation rates because of side effects were as low as 1.4%.

The drug is contraindicated in patients with hypersensitivity to any of the tetracyclines and may cause permanent tooth discoloration if used during the tooth development phase. It should only be used when indicated to avoid development of antimicrobial resistance and should be discontinued in the event of  Clostridium difficile-associated diarrhea (antibiotic-associated colitis), or intracranial hypertension occur.

According to GlobalData analysis acne vulgaris (acne) is one of the most common dermatological conditions, affecting around 90% of the world’s population at some point in their lifetime. Other major classes of drugs used for the treatment of acne are retinoids, anti-androgens, antibiotics, and benzoyl peroxide.

Sarecycline will face competitions from two late-stage pipeline drugs with antibiotic properties: Foamix Pharmaceuticals’ FMX-101 and Dermira’s olumacostat glasaretil. Along with these drugs, Sarecycline will provide newer treatment options for patients with acne vulgaris.

New Release 

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Avoid, if possible or use appropriately: Antibiotics in early pregnancy increases risk of spontaneous miscarriage.

courtesy: fortworthent.net

Use of certain antibiotics in early pregnancy increases the risk of miscarriage, says the results of new nested case control study published in current issue of Canadian Medical Association Journal on May 1, 2017.

Macrolides (excluding erythromycin), quinolones, tetracyclines, sulfonamides and metronidazole consumption increases the odds of spontaneous abortion during early pregnancy as compared to cephalosporin, penicillin or no antibiotics at all.

 Antibiotics are widely prescribed throughout pregnancy and existing literature provides conflicting views on their use.

Flory T. Muanda, M.D and her colleagues analyzed data from Quebec Pregnancy Cohort (1998–2009) and identified 182 369 pregnancies that met the inclusion criteria.

The women were between 15–45 years of age and was continuously covered by insurance for at least a year before the pregnancy. Out of these cohort of women, 8702(4.7%) suffered spontaneous pregnancy loss before 20 weeks of gestation and were considered as cases.

For every case ending in abortion, the researchers identified 10 control patients who matched the case by age, year of pregnancy and gestational dating.

Antibiotic exposure was identified by information obtained from Quebec Public Prescription Drug Insurance Plan. All women who filled atleast one prescription for any type of antibiotic between the first day of gestation and the abortion date or just before pregnancy but it’s use extended around the conception period were considered as exposed.

To study the baseline risk of abortion among the general population, a category was formed of patients who were pregnant with no antibiotic exposure.

About 12,446 (13%) patients consumed antibiotics during pregnancy, of which 1428 ended in spontaneous abortion (16.4% of all pregnancies ending in spontaneous abortion).

The mean gestational age at abortion was 14.1week.

Among the control group, 11,018 (12.6%) of patients were exposed to antibiotics.

Those women who had abortion were a year older than the control group, more likely to visited hospital ER and reported consuming more medicines in general.

Interpretation:

• After accounting for the confounders, it was seen that nitrofurantoin, erythromycin, penicillins, or cephalosporins were the safest to prescribe with no increased risk of abortion.
• Use of macrolides (excluding erythromycin), quinolones, tetracyclines, sulfonamides and metronidazole during early pregnancy was associated with an increased risk of spontaneous abortion.
• The odds of suffering spontaneous abortion were greatest with Norfloxacin (odds ratio 4.81) and Levofloxacin (odds ratio 3.28) as compared to no antibiotic.
• Safety of Nitrofurantoin supports its use as an alternative to trimethoprim–sulfamethoxazole for the treatment of urinary tract infection during pregnancy.
• The study findings supported the current guidelines of not using tetracyclines and quinolone class of drugs in pregnancy.
• Metronidazole exposure was also associated with 70% increased risk of spontaneous abortion, which is similar to a previous Medicaid cohort study that showed a 67% increased risk of spontaneous abortion.

The study has a very large sample size and documented information about exposure and the outcome, eliminating recall bias. The study design also minimized selection bias.

Severity of infection, tobacco/ alcohol use, folic acid intake may serve as confounders and may account for some of the findings, but the researchers took measures like using 2 active comparator groups to address these confounders.

The article full text can be accessed here.