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Niravam (Alprazolam) - Summary

 

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NIRAVAM SUMMARY

NIRAVAM™
(ALPRAZOLAM ORALLY DISINTEGRATING TABLETS)
rx only

NIRAVAM™ (alprazolam orally disintegrating tablets) contains alprazolam which is a triazolo analog of the 1,4 benzodiazepine class of central nervous system-active compounds. NIRAVAM™ is an orally administered formulation of alprazolam which rapidly disintegrates on the tongue and does not require water to aid dissolution or swallowing.

NIRAVAM™ (alprazolam orally disintegrating tablets) is indicated for the following:

Anxiety Disorders

NIRAVAM™ is indicated for the management of anxiety disorder (a condition corresponding most closely to the APA Diagnostic and Statistical Manual [DSM-III-R] diagnosis of generalized anxiety disorder) or the short-term relief of symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

Anxiety associated with depression is responsive to alprazolam.

Panic Disorder

NIRAVAM™ is also indicated for the treatment of panic disorder, with or without agoraphobia.

Studies supporting this claim were conducted in patients whose diagnoses corresponded closely to the DSM-III-R/IV criteria for panic disorder (see CLINICAL STUDIES).

Demonstrations of the effectiveness of alprazolam by systematic clinical study are limited to
4 months duration for anxiety disorder and 4 to 10 weeks duration for panic disorder; however, patients with panic disorder have been treated on an open basis for up to 8 months without apparent loss of benefit. The physician should periodically reassess the usefulness of the drug for the individual patient.

NIRAVAM NEWS HIGHLIGHTS

Published Studies Related to Niravam (Alprazolam)

Absence of food effect on the extent of alprazolam absorption from an orally disintegrating tablet. [2007.08]

Cognitive, psychomotor and actual driving performance in healthy volunteers after immediate and extended release formulations of alprazolam 1 mg. [2007.05]

Current approaches to the pharmacologic treatment of anxiety disorders. [2007]

Different acute tolerance development to EEG, psychomotor performance and subjective assessment effects after two intermittent oral doses of alprazolam in healthy volunteers. [2007]

Combining alprazolam with systematic desensitization therapy for dental injection phobia. [2007]

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Clinical Trials Related to Niravam (Alprazolam)

A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety [Completed]

Trial to Compare Time to Response in the Symptoms of Anxiety to Concomitant Treatment With Niravam(TM) and an SSRI or SNRI to Treatment With an SSRI or SNRI Alone in Subjects With Generalized Anxiety Disorder or Panic Disorder [Completed]

PharmacofMRI (Functional Magnetic Resonance Imaging) of Anxiolytic Medications (Alprazolam) [Recruiting]

Staccatoâ„¢ Alprazolam for Inhalation in Panic Attack [Completed]

Abuse Liability of Staccato Alprazolam [Recruiting]

more>>

Page last updated: 2008-01-01

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