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Product name
Date registered
Evaluation commenced
Decision date
Approval time
142 (255 working days
Active ingredients
Registration type
New generic medicine


Short-term symptomatic treatment of anxiety including treatment of anxious patients with some symptoms of depression.

Panic disorder

The treatment of panic disorder with or without some phobic avoidance, and for blocking or attenuation of panic attacks and phobias in patients who have agoraphobia with panic attacks.

The diagnostic criteria for panic disorder in DSM-III-R are as follows:

The panic attacks (discrete periods of intense fear or discomfort), at least initially, are unexpected. Later in the course of this disturbance, certain situations (e.g. driving a car or being in a crowded place) may become associated with having a panic attack. These panic attacks are not triggered by situations in which the person is the focus of others' attention (as in social phobia).

The diagnosis requires four such attacks within a four week period, or one or more attacks followed by at least a month of persistent fear of having another attack.

The panic attacks must be characterised by at least four of the following symptoms: dyspnoea or smothering sensations; dizziness, unsteady feelings or faintness; palpitations or tachycardia; trembling or shaking; sweating; choking; nausea or abdominal distress; depersonalisation or derealisation; paraesthesiae; flushes (hot flashes) or chills; chest pain or discomfort; fear of dying; fear of going crazy or of doing something uncontrolled.

Note. Attacks involving four or more symptoms are panic attacks; attacks involving fewer than four are limited symptom attacks.

At least some of the panic attack symptoms must develop suddenly and increase in intensity within ten minutes of the beginning of the first symptom noticed in the attack.

The panic attack must not be attributable to some known organic factor, e.g. amphetamine or caffeine, intoxication, hyperthyroidism.

The efficacy of alprazolam in conditions where the above criteria are not met has not been established. The risk versus benefits of alprazolam use in milder disorders, which do not meet the above criteria, has not been evaluated. Although current evidence supports the long-term clinical effectiveness of alprazolam in panic disorder, the continuing use of alprazolam needs to be weighed against the difficulties that can occur with dependence and discontinuation.

The results of a long-term study in patients taking alprazolam (ie. beyond three months) suggest that many patients continue to benefit from alprazolam therapy and that alprazolam efficacy is maintained for up to eight months.

The physician should periodically reassess the usefulness of the drug for each patient.

A comparative study of alprazolam and placebo in the treatment of panic attacks in patients with panic disorder involved 543 patients over an eight week period. Alprazolam was significantly more effective than placebo in reducing the total number of panic attacks (p < 0.0001); at week 4, 46.8% of alprazolam patients had achieved zero total panic attacks when compared to 27.1% of placebo patients.

Panic disorders are often severe, chronic illnesses that cause a high level of work and social disability, increased substance abuse and potentially increased morbidity and mortality.

Psychological and social factors are important in the pathogenesis of panic attacks, either acting alone or in combination with biological factors. Prolonged pharmacological therapy may be used as an adjunct to psychosocial therapy in the treatment of patients with panic disorders.

Registration process

First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine

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