Allergan, Paratek announce positive results for sarecycline as an acne therapy
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Allergan and Paratek Pharmaceuticals announced today that two phase 3 trials of sarecycline yielded encouraging 12-week results for the treatment of moderate-to-severe acne, according to a press release.
The once-daily, oral, narrow-spectrum tetracycline-deprived antibiotic has anti-inflammatory properties.
Researchers on the two studies aimed to replicate previous randomized, multicenter, double-blind, placebo-controlled studies that evaluated a 1.5 mg/kg dose of the drug for safety and efficacy outcomes. Eligible participants were treated with 60 mg, 100 mg, or 150 mg of the drug daily or placebo once daily. The study drug was associated with a significant improvement over placebo with regard to efficacy outcomes (P < .004).
Nausea occurred in less than 4% of the cohort, while nasopharyngitis and headache occurred in fewer patients than that. Less than 2% of the cohort discontinued due to adverse events. – by Rob Volansky