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Zonisamide

Zonisamide (brand name Zonegran®) is a sulfonamide anticonvulsant approved for use as an adjunctive therapy in adults with partial-onset seizures. It was discovered by researchers at Dainippon Sumitomo Pharma (大日本住友製薬: Dainippon Sumitomo Seiyaku (formerly Dainippon Pharmaceutical (大日本製薬: Dainippon Seiyaku)), who launched it in 1989 as Excegran® in Japan. It was marketed by Élan in the United States starting in 2000 as Zonegran®, before Élan transferred their interests in zonisamide to Eisai (エーザイ) in 2004. more...

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Eisai also markets Zonegran® in Asia (China, Taiwan, and fourteen others) and Europe (starting in Germany and the United Kingdom).

Uses

Approved

Zonisamide is approved in the United States, United Kingdom, and Japan for adjunctive treatment of partial seizures in adults.

Unapproved/Off-Label/Investigational

An open trial on zonisamide in seven Parkinson's disease patients had positive results, according to this 2001 report. Since then, it has been reported to treat the resting tremor that other therapies may leave behind. By early November of 2005, Dainippon Sumitomo had filed a NDA for the use of zonisamide in Parkinson's disease; it is to be marketed as Tremode®.

Metabolism

Zonisamide is metabolized mostly by the CYP3A4 isoenzyme, but also CYP3A7 and CYP3A5, to 2-(sulphamoylacetyl)-phenol via reductive cleavage of the 1,2-benzisoxazole ring.

Mechanism of Action

The exact mechanism of action is not known for zonisamide. According to Leppik, while zonisamide may be a carbonic anhydrase inhibitor like acetazolamide, this is not one of the primary mechanisms of action, which might be blocking repetitive firing of voltage-gated sodium channels and reduction of T-type calcium channel currents, or by binding allosterically to GABA receptor like the benzodiazepines and muscimol, or increasing the levels of the glutamate transport protein in the brain while decreasing the amount of GABA transport protein, in other words, inhibiting the uptake of the inhibitory neurotransmitter GABA while enhancing the uptake of the excitatory neurotransmitter glutamate.

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Barr Receives Approval for Zonisamide Capsules, 25 mg, 50 mg & 100 mg
From PR Newswire, 12/23/05

WOODCLIFF LAKE, N.J., Dec. 23 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that it's subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food and Drug Administration (FDA) for its application to manufacture and market Zonisamide Capsules, 25 mg, 50 mg & 100 mg, the generic equivalent to Zonegran(R) Capsules, distributed by Eisai Inc. The Company plans to launch its product immediately.

Zonisamide Capsules, 25 mg, 50 mg & 100 mg, are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide had total annual sales of approximately $175 million, based on IMS sales data for the twelve months ended October 2005.

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

Forward-Looking Statements

Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the outcome of litigation arising from challenging the validity or non-infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.

The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.

CONTACT: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720, ccox@barrlabs.com

Web site: http://www.barrlabs.com/

Company News On-Call: http://www.prnewswire.com/comp/089750.html

COPYRIGHT 2005 PR Newswire Association LLC
COPYRIGHT 2005 Gale Group

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