January 6, 2008
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Xanax XR (alprazolam) is approved for the treatment of panic disorder. The extended-release tablets are contraindicated in patients with known sensitivity to benzodiazepines or with acute narrow-angle glaucoma. The drug is also contraindicated for use with ketoconzole and itraconazole.
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NEWS
WASHINGTON — The Food and Drug Administration has approved the abbreviated new drug application (ANDA) of Mylan Laboratories Inc. to market a generic version of Xanax XR. Pfizer Inc. manufactures the brand name panic-disorder treatment.
Known under its generic name of alprazolam, the brand product had sales of about $100 million for the 12 months ending in June.
Mylan’s extended-release tablets will be available in 0.5-, 1-, 2- and 3-mg strengths.
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The Medical Letter, Xanax XR for panic disorder. 2003;45(1157):43-44.
Therapy for panic disorder often includes benzodiazepines to provide rapid relief of symptoms, used together with antidepressant medications, which can take weeks to become effective. An extended release formulation of the benzodiazepine alprazolam (Xanax XR) is now available.
The Medical Letter consultants found only two published studies that showed extended-release alprazolam is effective. In one of these studies, extended-release
alprazolam was less effective than immediate-release alprazolam or placebo in some measures. In the other study, response rates to placebo were 61%-81%, making drug effectiveness difficult to substantiate. Two 8-week long studies did not show superiority over placebo. Although extended-release alprazolam requires fewer doses per day than immediate-release alprazolam, clinical data showing that this new formulation is more effective to reduce anxiety between doses are not available. Cognitive behavioral therapy and antidepressants are preferred for long-term treatment of panic disorder. Xanax XR may provide immediate symptoms relief, but needs to be stopped as soon as possible to avoid physical or psychological dependence.
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NOVADEL INITIATES HUMAN STUDY OF ALPRAZOLAM LINGUAL SPRAY.
NovaDel Pharma Inc. (AMEX:NVD), Flemmington, N.J., has commenced a pilot pharmacokinetic feasibility study in humans of a lingual spray version of alprazolam, a widely prescribed anti-anxiety medication marketed as Xanax(R) by Pfizer, Inc, and as a generic by several producers.
The drug’s new formulation utilizes NovaDel’s patented lingual spray drug delivery technology.
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Use of alprazolam in premenstrual syndrome - Tips from Other Journals
Alprazolam, a benzodiazepine, has been studied as a possible treatment for the anxiety- and depression-like components of premenstrual syndrome, but the results of these studies have been inconclusive. Schmidt and colleagues performed a randomized, double-blind, placebo-controlled crossover trial of alprazolam in women with prospectively confirmed premenstrual syndrome.
Women were recruited by newspaper advertisements or physician referral. Twenty women completed the study. A diagnosis of premenstrual syndrome was confirmed through the use of daily self-rating symptom checklists. The women were randomized to receive alprazolam or placebo from day 16 of the menstrual cycle until the onset of menses. Over four menstrual cycles, the alprazolam dose was increased from 0.25 mg to 0.75 mg three times a day. The women completed checklists daily and a battery of psychiatric screening questionnaires twice monthly. Results of these measures in placebo and alprazolam months were then compared.
No differences were found in self-rating scores between alprazolam months and placebo months. Results of psychiatric screening also did not differ between treatment and placebo months, except for a statistically, but not clinically significant, improvement in depression scores during alprazolam treatment.
The authors conclude that no uniform improvement in symptoms of premenstrual syndrome occurs in patients receiving alprazolam, although patients with strong depressive symptoms may have some benefit. (Archives of General Psychiatry, June 1993, vol. 50, p. 467)
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