Niravam (Alprazolam) - Summary

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.

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NEWS HIGHLIGHTS

Published Studies Related to Niravam (Alprazolam)

Does oral alprazolam affect ventilation? A randomised, double-blind, placebo-controlled trial. [2009.05]
The respiratory effects of benzodiazepines have been controversial...

Absence of food effect on the extent of alprazolam absorption from an orally disintegrating tablet. [2007.08]
Study Objective... The clinical significance of the difference in rate of alprazolam absorption is unknown but thought to be minimal.

Cognitive, psychomotor and actual driving performance in healthy volunteers after immediate and extended release formulations of alprazolam 1 mg. [2007.05]
CONCLUSIONS: The acute impairing effects of alprazolam XR 1 mg on driving and psychomotor functions were generally less, as compared to its immediate-release equivalent, but still of sufficient magnitude to increase the risk of becoming involved in traffic accidents.

Current approaches to the pharmacologic treatment of anxiety disorders. [2007]
Despite their high prevalence, the anxiety disorders are underdiagnosed and undertreated.

Different acute tolerance development to EEG, psychomotor performance and subjective assessment effects after two intermittent oral doses of alprazolam in healthy volunteers. [2007]
BACKGROUND/AIMS: Benzodiazepines (BZDs) are the most effective of the psychotropic drugs in the treatment of anxiety disorders. Tolerance has been reported for the majority of BZDs after chronic administration. However, little attention has been paid to the possibility that tolerance might be present after the intermittent oral administration of BZDs. The objectives of the present study were to assess tolerance development after the administration of two intermittent single oral doses of alprazolam given 15 days apart in healthy volunteers, and to compare the results obtained using measures from different domains: neurophysiological, psychomotor and subjective... CONCLUSIONS: The administration of two single oral doses of alprazolam, 2 weeks apart in healthy volunteers, yielded the same PKs on both occasions, but significant changes were observed in the PD profile. Acute tolerance was observed after the second administration. Two patterns of acute tolerance development were obtained: (1) impairments of psychomotor performance and relative beta-1 activity, and (2) subjective assessments and relative alpha activity. (c) 2007 S. Karger AG, Basel.

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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]
This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study

visits (four periods of 7 3 - day duration): Screening (Visit 1), Treatment Period 1 (Visit

2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone visit]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam.

The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's

health status.

Bioequivalence of Alprazolam Sublingual vs Oral Tablets [Recruiting]
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.

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]
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravamâ„¢ and a newly prescribed SSRI/SNRI to that in subjects treated with a newly prescribed SSRI/SNRI alone. Subjects must be at least 18 years of age and positive for Generalized Anxiety Disorder or Panic Disorder. Subjects will be randomized to receive concomitant Niravam and an SSRI/SNRI or an SSRI/SNRI alone during the study. Most symptom evaluations will be done using an automated phone interview system. There are 4 clinic visits.

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

Bioequivalence Of A Test Alprazolam Sublingual Formulation Compared To A Commercial Sublingual Formulation [Not yet recruiting]
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from sublingual formulation expected to be used commercially in Brazil.

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