Amcinonide
Clinical data | |
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Trade names | Cyclocort |
AHFS/Drugs.com | Micromedex Detailed Consumer Information |
Routes of administration | Topical |
ATC code | |
Legal status | |
Legal status |
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Hepatic | |
Excretion | Urine and bile |
Identifiers | |
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JSmol) | |
Density | 1.33 g/cm3 |
Boiling point | 635.9 °C (1,176.6 °F) |
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Amcinonide (trade name Cyclocort) is a
Medical Uses
Corticosteroids applied topically are used for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly
Dermatitis, Psoriasis, & Eczema
0.1% Amcinonide cream or ointment is typically applied two to three times daily to treat dermatitis, psoriasis, and/ or eczema while the same strength lotion is usually only used twice daily. This information can be found on the FDA approved label or from the prescribing doctor or pharmacist.
Adverse Effects
Amcinonide exhibits side effects common among other corticosteroids. While these reactions are uncommon for most delivery vehicles, the use of occlusive dressings increases the likelihood of such effects.[5] These include burning, itching, skin dryness and irritation, acne/ pimples, skin atrophy, blistering, and/ or skin discoloration.[5][10] While most side effects are mild, a medical professional should be contacted if severe rash, acne, skin deterioration, excessive hair growth, or abnormal weight gain occur. Following package insert instructions for a single topical dose, as detailed on the package insert, should not lead to any toxicities.[10]
Pharmacology
Cyclocort is a synthetic corticosteroid created to imitate natural glucocorticoids. In order to do so, amcinonide acts as an agonist to target glucocorticoid receptors. After interacting with the receptor, endocytosis occurs at which point the drug can bind to DNA within the cell. Gene expression is subsequently modified to produce anti-inflammatory mediators while preventing the formation of inflammatory agents thus reducing overall inflammation and immune system response.[11]
Mechanism of Action
The mechanism by which Amcinonide causes anti-inflammatory responses is unclear with current research focused on similar topical steroids that may possess the same mechanism.
Metabolism & Elimination
Amcinonide undergoes
History
Amcinonide was first developed in the
Research & Clinical Trials
Amcinonide is produced from the reaction of 16α,17α-Cyciopentylidenedioxy-9α-fluoro-11β,21-dihydroxy-1,4pregnadiene-3,20-dione and acetic anhydride in which 11.1g and 5.5mL, respectively, of each reactant are consumed to produce 7.0g of pure product.[15] Only 4.7% of patients in clinical trials reported experiencing side effects as a result of continued use of Amcinonide. Specifically, in one acceptability study conducted on a weekly basis, one-fifth of patients using both placebo and Cyclocort 0.1% lotion reported various discomforts at multiple interviews.[18] The outcomes of relevant trials are included below.
One of the initial clinical studies into Amcinonide, conducted by Woodford & Barry, 1979, compared topical applications Amcinonide to
A French study by Binet et al., 1979, compared 0.1% Amcinonide ointment to equal strength
Similar to the Woodford & Barry study in 1977, Woodford & Haigh, 1979 sought to determine the potency of 0.1% Amcinonide through the use of a vasoconstrictor assay. Three equal strength formulations of Amcinonide were prepared (cream, combination-ointment, combination-cream) were compared against similar corticosteroids already on the market in the United Kingdom (Betnovate,
In a study conducted by Fedler, Pilz, & Frosch, 1993, the long term usage of Amcinonide, along with other topical corticosteroids, was tested on women with a history of dermatitis who had otherwise been relatively healthy. It was found that corticosteroid usage may eventually cause
Commercialization
First introduced to the market in 1979 as 0.025% and 0.1% creams, Amcinonide has been available continuously since then, being prescribed for a variety of similar
After acquiring production rights from American Home Products, Amcinonide is currently being produced in the United States by
While the initial patents obtained by American Cyanamid company in the late 1970s/ early 1980s for ointment, cream, and lotion formulations have expired, new patents have been obtained for alternative transdermal delivery methods.[26][27] More recently, however, the drug formulation itself has not been patented but ways to incorporate it into occlusive dressings such as a pressure sensitive adhesive layer as demonstrated by Senju USA, Inc. in 2012 - 2014. Specifically, these new dosage forms target diseases of the eyelid such as blepharitis, allergic conjunctivitis, vernal keratoconjunctivitis, and atopic keratoconjunctivitis.[28][29][30] This is significant as previous formulations of Amcinonide have not been used to treat ocular inflammations. Patents such as these are likely to continue to be published as research searches for low cost alternatives to new drugs to increase bioavailability and patient compliance.
Regulatory
Taro Pharmaceuticals obtained FDA approval to begin production of Amcinonide cream in 2002 after proving the product was bioequivalent to Cyclocort products already on the market. This was the first generic Amcinonide product to be sold in the United States, thus introducing a lower-priced alternative for patients with applicable dermatological ailments.[31] In 2003, Fougera Pharmaceutical became the main competitor to Taro after acquiring FDA approval for production of 0.1% Amcinonide cream.[32]
In 2009, Taro Pharmaceuticals was warned by the FDA that they were not meeting good manufacturing practices for their ointment and that their final product was non-sterile. Following additional FDA investigations, this was eventually resolved after two years, at which point the company regained good standing with FDA regulations.[33][34]
References
- ^ Drugs.com: Amcinonide topical
- PMID 6383735.
- ^ DrugBank.ca: Amcinonide Pharmacoeconomics
- ^ PubChem.gov:Amcinonide
- ^ a b c Fougera.com: Amcinonide Ointment USP, 0.1% Archived 2015-11-21 at the Wayback Machine
- ^ a b Drugs.com:Amcinonide Dosage
- ^ FDA.gov:Fougera Amcinonide Ointment Label
- ^ FDA.gov:Fougera Amcinonide Cream Label
- ^ FDA.gov:Taro Amcinonide Labels
- ^ a b Drugs.com: Amcinonide Topical
- ^ NCIt.NCI.NIH.gov: Amcinonide
- ^ DrugBank.ca: Amcinonide
- ^ a b DrugBank.ca:Amcinonide Pharmacology
- ^ Genome.jp:Drug D01387
- ^ a b c Pharmaceutical Manufacturing Encyclopedia: Amcinonide
- ^ FundingUniverse.com: History of Wyeth
- ^ NYtimes.com:Pfizer Agrees to Pay $68 Billion for Rival Drug Maker Wyeth
- ^ DrugBank.ca:Cyclocort (Amcinonide) Archived 2016-03-04 at the Wayback Machine
- ^ Woodford R, Barry BW, Frosch PJ (1977). "Activity and Bioavailability of Amcinonide and Triamcinolone Acetonide in Experimental and Proprietary Topical Preparations". Current Therapeutic Research. 21 (6): 877–886.
- ^ Binet O, Brunetiere RA, Bruneau O, Bogaievsky Y (1979). "A Double-Blind Comparative Trial Between Amcinonide and Fluocinonide in Dermatology". Current Therapeutic Research. 25 (4): 500–507.
- ^ Woodford R, Haigh JM (1979). "Bioavailability and Activity of 0.1% Amcinonide Preparations: Comparison with Proprietary Topical Corticosteroid Formulations of Differing Potencies". Current Therapeutic Research. 26 (3): 301–310.
- PMID 8449700.
- ^ FDA.gov:Amcinonide Approval
- ^ Sandoz.com:Fougera Acquisition Archived 2015-09-10 at the Wayback Machine
- ^ a b DrugBank.ca:Amcinonide Identification
- ^ Google.com: Topical Ointment Patent
- ^ Google.com: Topical Ointment Patent 2
- ^ Google: Transdermal Drug Delivery System and Method Patent
- ^ Google.com: Transdermal Drug Delivery System and Method Patent 2
- ^ Google.com: Transdermal Drug Delivery System and Method Patent 3
- ^ TheFreeLibrary.com:Taro Pharmaceuticals Receives FDA Approval for Amcinonide Cream USP, 0.1% Archived 2016-03-16 at the Wayback Machine
- ^ FDA.gov:Amcinonide Approval
- ^ PharmCast.com:FDA Warning Letter to Taro Archived 2011-06-17 at the Wayback Machine
- ^ BusinessWire.com:Taro Resolves FDA Warning Letter