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)
Comparison of alprazolam versus captopril in high blood pressure: a randomized controlled trial. [2011.08]
CONCLUSION: A significant association exists between the level of BP and anxiety in hypertensive ED patients. Alprazolam is as effective as captopril in lowering BP in ED patients with an initial SBP > 160 mmHg.
Efficacy of alprazolam sublingual tablets in the treatment of the acute phase of panic disorders. [2011.03]
CONCLUSIONS: Alprazolam has been demonstrated to have efficacy, safety and good tolerability in the treatment of the acute phase of panic disorder, the sublingual tablets showing some comparative advantages.
The efficacy and safety of alprazolam versus other benzodiazepines in the
treatment of panic disorder. [2011]
We performed a meta-analysis of all single- or double-blind, randomized
controlled trials comparing alprazolam to another benzodiazepine in the treatment
of adult patients meeting the Diagnostic and Statistical Manual of Mental
Disorders, Third or Fourth Edition, criteria for panic disorder or agoraphobia
with panic attacks...
The effects of alprazolam on tinnitus: a cross-over randomized clinical trial. [2009.11]
CONCLUSIONS: These results suggest that although alprazolam did not improve the THI score or sensation level of loudness significantly, it has a desirable effect on VAS. Further work is needed to determine the beneficial effects of alprazolam in distressed or depressed patients.
Does oral alprazolam affect ventilation? A randomised, double-blind, placebo-controlled trial. [2009.05]
The respiratory effects of benzodiazepines have been controversial...
Clinical Trials Related to Niravam (Alprazolam)
Bioequivalence of a New Sublingual and a Reference Alprazolam Immediate Release Tablet 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 an existing commercial immediate release tablet
formulation.
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 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.
Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 [Recruiting]
The purpose of this study is to determine the way by which Alprazolam (Xanax) an
anti-anxiety drug affects specialized molecules in your brain called GABA (A) receptors that
alter your body's ability to defend itself from low blood sugar (hypoglycemia). We
hypothesize that prior activation of GABA (A) receptors may result in blunting of
counterregulatory responses during subsequent hypoglycemia and exercise.
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.
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