Drugs in the Pipeline
The FDA has granted Breakthrough Therapy designation to AXS-05 (Axsome Therapeutics) for the treatment of Alzheimer disease (AD) agitation.
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Three major medical organizations have issued recommendations for the diagnosis and treatment of advanced prostate cancer, including metastatic hormone-sensitive disease and nonmetastatic and metastatic castration-resistant disease.
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The use of electrical stimulation devices (ESDs) to treat self-injurious or aggressive behavior has been banned by the Food and Drug Administration (FDA).
Drugs in the Pipeline
The Nonprescription Drugs Advisory Committee (NDAC) of the Food and Drug Administration (FDA) has recommended the approval of the New Drug Application (NDA) from GlaxoSmithKline for an over-the-counter (OTC) nicotine mouth spray to aid in smoking cessation (9 to 6 vote). The nicotine mouth spray (NMS) delivers 1mg nicotine per spray; each dispenser would deliver…
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According to the results of a recent review, the efficacy of nicotine replacement therapy (NRT) in achieving long-term smoking cessation varies based on NRT delivery method, dosage, and timing of initiation.
Safety Alerts and Recalls
A preliminary analysis of long-term follow-up data (up to 5 years) involving patients with peripheral arterial disease (PAD) treated with paclitaxel-coated products revealed a ‘potentially concerning’ signal of increased long-term mortality when compared with those treated with uncoated devices, according to the Food and Drug Administration (FDA). Among the 3 trials that included 5-year follow-up…
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Results from a placebo-controlled study evaluating Chantix (varenicline; Pfizer) in pediatric patients 12-16 years of age showed that the smoking cessation treatment was not associated with a significant increase in abstinence rates in this patient population.
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The case involved a 55-year-old female patient who had been admitted to the hospital after suffering injuries from a car accident.
Drugs in the Pipeline
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.
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The male patient presented in 2009 with a "3-year history of multiple interconnecting comedones in the axilla and inguinal regions, as well as scarring from previous lesions."
