PurTox steps closer to competing against Botox
PurTox -- a potential future competitor to the wrinkle relaxer Botox Cosmetic -- announced a successful completion of 400 person study on the effects of PurTox.
The study found high satisfaction by participants with respect to PurTox reducing the appearance of frown lines. Another direct Botox competitor called Reloxin is also pending FDA approval but is distributed outside of the US.
By Tom Seery for Real Beauty News
Press release:
Mentor Corporation Announces Completion of PurTox(R) 3A Study
Wednesday October 1, 9:00 am ET SANTA BARBARA, Calif.--(BUSINESS WIRE)--Mentor Corporation (NYSE:MNT - News), a leading supplier of medical products for the global aesthetic market, today announced completion of the first of three Phase 3 clinical trials with its purified botulinum Type A neurotoxin (PurTox®) for the reduction of glabellar rhytides (frown lines).
This newly completed study involved 400 subjects at ten investigational sites in the United States. Subjects received a single treatment with PurTox or placebo.
Using a validated 4-point photo scale as a reference, reduction in line severity was scored by subjects, investigators, and independent reviewers at time points through six months. Satisfaction with treatment outcome was measured using a standard global satisfaction assessment tool and safety was assessed by adverse event tracking.
The results for the primary efficacy endpoint and for each of the eight secondary efficacy endpoints were all highly significant (p ≤0.0001 in each case). For each of these endpoints, the findings were indicative of a substantial treatment effect. In addition, a very large percentage of subjects expressed a high degree of satisfaction with the treatment outcome. Data from the three Phase 3 studies will be used to support the filing of a BLA (Biologics License Application) with the U.S. Food and Drug Administration. The remaining two Phase 3 studies for this indication have completed enrollment and are currently in the follow-up stage.
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