[a] Patients who showed at least a 2-grade improvement from baseline value on the HDSS 4 weeks after both of the first two treatment sessions or had a sustained response after their first treatment session and did not receive re-treatment during the study.

Duration of response was calculated as the number of days between injection and the date of the first visit at which patients returned to 3 or 4 on the HDSS scale. The median duration of response following the first treatment in BOTOX^®-treated patients with either dose was 201 days. Among those who received a second BOTOX^® injection, the median duration of response was similar to that observed after the first treatment.

In study 2, 320 adults with bilateral axillary primary hyperhidrosis were randomized to receive either 50 Units of BOTOX^® (n=242) or placebo (n=78). Treatment responders were defined as subjects showing at least a 50% reduction from baseline in axillary sweating measured by gravimetric measurement at 4 weeks. At week 4 post-injection, the percentages of responders were 91% (219/242) in the BOTOX^® group and 36% (28/78) in the placebo group, p < 0.001.The difference in percentage of responders between BOTOX^® and placebo was 55% (95% CI = 43.3, 65.9).

Blepharospasm: Botulinum toxin has been investigated for use in patients with blepharospasm in several studies. In an open label uncontrolled study, 27 patients with essential blepharospasm were injected with 2.0 Units of BOTOX^® at each of six sites on each side. One patient had not received any prior treatment. Twenty-six of the patients had not responded to therapy with benztropine mesylate, clonazepam and/or baclofen. Three of the 26 patients continued to experience spasms following muscle stripping surgery. Twenty-five of the 27 patients treated with botulinum toxin reported improvement within 48 hours. One patient was controlled with a higher dosage at 13 weeks post initial injection and one patient reported mild improvement but remained functionally impaired.²

In another study, 12 patients with blepharospasm were evaluated in a double-blind, placebo-controlled study. Patients receiving botulinum toxin (n=8) improved compared with the placebo group (n=4). The mean dystonia score improved by 72%, the self-assessment score rating improved by 61%, and a videotape evaluation rating improved by 39%. The effects of the treatment lasted a mean of 12.5 weeks.³

One thousand six hundred eighty-four patients with blepharospasm who were evaluated in an open label trial showed clinical improvement as evaluated by measured eyelid force and clinically observed intensity of lid spasm, lasting an average of 12.5 weeks prior to the need for re-treatment.⁴

Strabismus: It is postulated that when used for the treatment of strabismus, the administration of BOTOX^® affects muscle pairs by inducing an atrophic lengthening of the injected muscle and a corresponding shortening of the muscle’s antagonist; it was on the basis of this hypothesis that clinical studies were conducted. Six hundred seventy-seven patients with strabismus treated with one or more injections of BOTOX^® were evaluated in an open label trial. Fifty-five percent of these patients improved to an alignment of 10 prism diopters or less when evaluated six months or more following injection.⁵ These results are consistent with results from additional open label trials which were conducted for this indication.⁴

1. Data on file, Allergan, Inc. A randomized, multicenter, double-blind, placebo-controlled study of intramuscular BOTOX^® (botulinum toxin type A) purified neurotoxin complex (original 79-11 BOTOX^®) for the treatment of cervical dystonia. 1998.

2. Arthurs B, Flanders M, Codere F, Gauthier S, Dresner S, Stone L. Treatment of blepharospasm with medication, surgery and type Abotulinum toxin. Can J Ophthalmol 1987;22:24-28.

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