Medication Monitor

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Generic Name (Trade Name—Company)
  • August 29, 2011


    Treatment of moderate-to-severe chronic pain

    Janssen Pharmaceuticals announced the FDA approval of extended-release tapentadol tablets for management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. This Schedule II product will be marketed in 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg strengths.

    The efficacy of extended-release tapentadol was proven in various studies, including trials of patients with moderate-to-severe chronic low back pain and those with pain of diabetic peripheral neuropathy. The most common (≥10%) adverse reactions with this formulation were nausea, constipation, headache, dizziness, and somnolence.

    The product was approved with a Risk Evaluation and Mitigation Strategy to educate prescribers about the potential for abuse, misuse, overdose, and addiction from use of this opioid product.

  • August 25, 2011


    Treatment of urinary incontinence due to detrusor overactivity associated with neurologic conditions

    Allergan announced FDA approval of onabotulinumtoxinA for treatment of urinary incontinence due to detrusor overactivity associated with neurologic conditions, such as a spinal cord injury or multiple sclerosis, in adults who have an inadequate response or are intolerant to an anticholinergic medication.

    Approval was based on data from two Phase III trials in which 691 patients with urinary incontinence received onabotulinumtoxinA 200 units or placebo injected directly into the bladder muscle. Both studies showed significant reductions in the frequency of urinary incontinence episodes with onabotulinumtoxinA, compared with placebo (15.3 and 18 episodes/week vs. 10 and 7.9 episodes/week, respectively) within 2 weeks of treatment. The trend continued at week 6, with 19.9 and 19.6 episodes/week with active drug and 10.6 and 10.8 episodes/week with placebo in the two trials.

    Retreatment with onabotulinumtoxinA was provided to study participants when the clinical effect of the previous treatment wore off. This occurred at 42-48 weeks with onabotulinumtoxinA and 13-18 weeks with placebo.

    Adverse events reported following the initial injection of onabotulinumtoxinA included urinary tract infections (49%), urinary retention (17%), fatigue (6%), constipation (4%), muscular weakness (4%), dysuria (4%), fall (3%), gait disturbance (3%), insomnia (3%), and muscle spasm (2%).

  • August 24, 2011


    Treatment of chronic hepatitis C infection in pediatrics

    FDA approved the combination treatment of peginterferon alfa-2a and ribavirin for treatment of pediatric patients 5 years and older with chronic hepatitis C infection who have compensated liver disease and no prior history of interferon therapy. The recommended dose of peginterferon alfa-2a for pediatric patients is 180 mcg per 1.73 m2 of BSA, given once weekly, to a maximum dose of 180 mcg, for 24 weeks for patients with genotypes 2 or 3 or for 48 weeks for those with other genotypes. It must always be given in combination with ribavirin, which is dosed based on the patients’ weight.

    Approval was based on data from 114 patients ages 5 through 17 years who had chronic hepatitis C and were previously untreated. Patients were randomized to peginterferon alfa-2a and ribavirin (n = 55) or peginterferon alfa-2a monotherapy (n = 59). Combination treatment resulted in significantly higher sustained virological responses (53%) compared with monotherapy (20%).

    An adverse event observed in this patient population with combination therapy was a delay in weight and height increases after 48 weeks of therapy compared with baseline. However, at the end of 2 years follow-up after treatment, most patients returned to baseline normative growth curve percentiles for height and weight. Other common adverse events were similar to those observed in adults (i.e., fatigue/asthenia, pyrexia, myalgia, headache).

    This combination regimen was originally approved in adults with chronic hepatitis C infections and is also approved for adults with chronic hepatitis C coinfected with HIV.

  • August 19, 2011


    Treatment of jock itch, athlete’s foot, and ringworm

    Apricus Biosciences announced that its NexMed USA subsidiary has received FDA clearance to market Tolnaftate-D, an OTC product that uses the company’s NextACT drug-delivery technology. This proprietary technology is designed to transiently loosen the tight junction between the cells of the sealed skin to allow more drug permeation, Apricus said in a news release.

    The active ingredient, tolnaftate, is an already-marketed agent used for the treatment of jock itch, athlete's foot, and ringworm.

  • August 18, 2011


    Treatment of children with central precocious puberty

    Abbott announced the approval of a new formulation of leuprolide acetate: depot suspension 11.25 mg and 30 mg for 3-month administration in children with central precocious puberty. The product was previously approved for 1-month dosing in 7.5 mg, 11.25 mg, and 15 mg dosage strengths.

    Approval was based on data from a 24-week study. It showed that two injections given 12 weeks apart resulted in sustained hormone suppression. In addition, the onset of hormone suppression was consistent with the 1-month formulation of leuprolide acetate in patients who had not been previously treated for central precocious puberty.

    The most common adverse events with depot leuprolide are injection-site pain and swelling, weight gain, headache, and altered mood. This new formulation is expected to be available in late August.