Fluconazole transdermal
`
`Publication info: Adis R&D Insight . (Dec 2, 2015).
`ProQuest document link
`
`Full text: DRUG PROFILE - Fluconazole transdermal
`Watson Pharmaceuticals (USA) was developing a patch to deliver fluconazole [ topical antifungal nail patch -
`Watson, fluconazole transdermal patch - Watson, onychomycosis patch - Watson] directly to the infected nail
`bed, utilising its proprietary transdermal technology, for the treatment of onychomycosis. However, following a
`review of clinical data, Watson has decided to discontinue development of this product.
`
`Fluconazole is a synthetic, triazole antifungal that is available as Diflucan ®by Pfizer as tablets, a powder for oral
`suspension, and as an injection for IV infusions. Although Diflucan ®was officially approved by the US FDA for
`the treatment of vaginal yeast infections in 1994, the FDA did not approve the use of fluconazole for
`onychomycosis.
`
`In Watson Pharmaceuticals' 2002 Annual Report, the company reported that positive results were obtained in
`its phase II, proof-of-concept trial in 2001. After 3 months, 78% of patients using the onychomycosis patch
`reported an improvement in fungal infection, compared with only 40% of placebo recipients. The incidence of
`adverse effects was also reportedly low in the trial.
`
`Two phase III trials of Watson Pharmaceuticals' fluconazole patch were underway in the US; enrolment in these
`two trials was completed in 2002. These 1-year treatment studies, with active and placebo groups, will include
`post-treatment follow-up evaluations for an additional 6 months. Preliminary results from these two trials
`indicated that although the product demonstrated a significant greater number of complete cures, compared
`with placebo, in one trial, a significant advantage over placebo was not seen in the second trial (Reference:
`809029201). Following further analysis of these clinical results, Watson announced in February 2004 that it has
`discontinued development of this product (Reference: 809030970).
`
`
`
`Adverse Event
`In two multicentre, double-blind, phase III trials, a total of 670 patients with toenail onychomycosis were
`randomised to receive topical antifungal therapy (fluconazole), or placebo, applied daily for 12 months.
`Preliminary results demonstrated that fluconazole was well tolerated, with a low incidence of adverse effects
`(Reference: 809029201).
`
`
`
`Therapeutic Trials
`Mycoses
`Preliminary results from two multicentre, double-blind, phase III trials in 670 patients with toenail onychomycosis
`showed that Watson's fluconazole transdermal patch may be beneficial in this population. Patients were
`randomised to receive topical antifungal therapy (fluconazole), or placebo, applied daily for 12 months. Patients
`were evaluated at 6, 12, 15 and 18 months. In one trial, antifungal therapy resulted in a significantly greater
`number of clinical cures, compared with placebo. Complete cure required success on three parameters: growth
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`of a completely clear nail, negative fungal culture, and a negative potassium hydroxide test. In the second trial,
`no significant difference in complete cure rates were seen between antifungal and placebo recipients
`(Reference: 809029201).
`
`
`
`References
`809029201. Watson Pharmaceuticals Announces Preliminary Results From Phase III Onychomycosis Trials.
`Watson Pharmaceuticals Inc. Media Release. : 10 Dec 2003. Available from: URL:
`http://www.watsonpharm.com. English. USA
`809030970. Watson Pharmaceuticals Reports Earnings Per Share Of $0.48 for Fourth Quarter 2003. Watson
`Pharmaceuticals Inc. Media Release. : 5 Feb 2004. Available from: URL: http://www.watsonpharm.com.
`English. USA
`
`
`
`History of Drug Development
`
`Event
`date
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`Update
`date
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`Update type
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`Significa
`nt
`
`Details
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`200311
`11
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`2003111
`1
`
`New Profile
`
`true
`
`New profile
`
`200311
`11
`
`2003111
`1
`
`Phase
`Change
`
`200312
`11
`
`2003121
`7
`
`Scientific
`Update
`
`true
`
`true
`
`Phase-III clinical trials in Onychomycosis in USA
`(Transdermal)
`
`Data from a media release have been added to the adverse
`events and Mycoses therapeutic trials sections (9029201)
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`200402
`05
`
`2004021
`2
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`Phase
`Change
`
`true
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`Discontinued - Phase-III for Onychomycosis in USA
`(Transdermal)
`
`201512
`01
`
`2015120
`2
`
`Financial
`Update
`
`true
`
`Credit Suisse financial data update
`
`
`
`Development Phases
`
`Phase
`
`Countr
`y
`
`Indication
`
`Route of
`Administration
`
`Formulati
`on
`
`On Fast
`Track
`
`Qualifiers and
`Comments
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`Onychomyc
`osis
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`Transdermal
`
`Patch
`
`false
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`Discontinued(II
`I)
`
`USA
`
`
`Subject: Azoles;Small-molecules;Triazoles
`
`Substance: Substance Substance: 1H-1,2,4-Triazole-1-ethanol, α-(2,4-difluoro-phenyl)-α-(1H-1,2,4-triazol-1-
`ylmethyl)-; CAS: 86386-73-4;
`
`Drug synonym: Fluconazole transdermal patch - Watson Pharmaceuticals, Onychomycosis patch - Watson
`Pharmaceuticals
`
`Molecular formula: C13H12F2N6O
`
`Generic name: Fluconazole transdermal
`
`Origin of substance: Fixed combination: No
`
`Route of administration: Transdermal
`
`Mechanism of action: 14-alpha-demethylase-inhibitors
`
`Therapeutic class: D1: Antifungals, DermatologicalD01A-C: Imidazole and triazole derivativesD01A-C15:
`Fluconazole
`
`Indication: Onychomycosis
`
`Drug status: Inactive
`
`Company information: Name: Watson Pharmaceuticals, Public, Is-Large-Pharma; Pharmaceutical; Role:
`Originator; Region: USA;
`
`Highest phase: Discontinued(III)
`
`Language: English
`
`Document type: Report
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`Publication title: Adis R&D Insight
`
`Publication type: Reports
`
`Publication date: Dec 2, 2015
`
`Date created: 2003-11-11
`
`Date revised: 2015-12-02
`
`Source attribution: Adis R&D Insight, © Publisher specific
`
`Accession number: 19867
`
`Document URL: http://dialog.proquest.com/professional/docview/1030574800?accountid=150768
`
`First available: 2012-08-02
`
`Updates: 2013-04-182014-01-212014-08-282015-01-292015-04-232015-12-03
`
`Database:
`
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