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Flemington Pharmaceutical Corp. Announces a New IND Filing for Clemastine Fumarate Lingual Spray to Treat Hay Fever Symptoms.


Business Editors & Health/Medical Writers

FLEMINGTON, N.J.--(BUSINESS WIRE)--June 13, 2000

Flemington Pharmaceutical Corp. (Flemington or the company)(OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:FLEM) (OTCBB:FLEMw) Tuesday announced that a new Investigational New Drug Application (IND) has been filed by the company with the United States Food and Drug

Administration.

The company's lingual lingual /lin·gual/ (ling´gwal)
1. pertaining to or near the tongue.

2. in dental anatomy, facing the tongue or oral cavity.


lin·gual
adj.
1.
 spray formulation of clemastine fumarate clem·a·stine fumarate
n.
An antihistamine used primarily to treat allergic rhinitis and allergic skin disorders.


clemastine fumarate (klem´
, the active ingredient in Tavist(R)(a), is being developed for the rapid treatment of hay fever symptoms. The IND was filed with the Division of Pulmonary Drug Products, and the initial Phase II clinical study will be conducted by Dr. Robert Naclerio, Pritzker School of Medicine The Pritzker School of Medicine is the M.D. granting unit of the Biological Sciences Division of the University of Chicago. It is located on the University's main campus in the Hyde Park portion of Chicago proper, and matriculated its first class in 1927.  at the University of Chicago in Chicago, Ill.

Dr. Harry A. Dugger, president/chief executive officer of the company, noted that the results of a pilot pharmacokinetics study with the clemastine lingual spray product suggested that significantly faster relief of nasal allergy symptoms could be possible than when compared with tablet formulations of the drug.

It is known that the OTC OTC

See: Over-the-counter.


OTC

See over-the-counter market (OTC).
 clemastine tablet dose (1.34 mg) is less sedating than the prescription tablet dose (2.68 mg). The company's clemastine fumarate lingual spray is expected to be one-half of the OTC dose, or 0.68 mg per activation, and may prove to be the first, truly non-sedating antihistamine antihistamine (ăn'tĭhĭs`təmēn), any one of a group of compounds having various chemical structures and characterized by the ability to antagonize the effects of histamine.  product to enter the $6 billion U.S. allergy market, and the first to be administered on an "as needed" regimen (PRN (PRiNter) The DOS name for the first connected parallel port. See DOS device names.  dosing).

Flemington is presently seeking a suitable development partner to assist in the development of this product and to market it after FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 approval.

Visit the company's Web site: www.flemington-pharma.com for further information.

Flemington Pharmaceutical Corp. is engaged in the development of novel drug delivery systems for presently marketed prescription and over-the-counter drugs. The delivery systems include lingual sprays and gelatin gelatin or animal jelly, foodstuff obtained from connective tissue (found in hoofs, bones, tendons, ligaments, and cartilage) of vertebrate animals by the action of boiling water or dilute acid.  bite capsules. The company believes that these delivery systems offer (i) improved drug safety by reducing the required drug dosage, therefore, reducing the side effects; (ii) improved dosage reliability; (iii) improved patient convenience and compliance; and (iv) enhanced dosage reliability. The company plans to develop such products through collaborate arrangements with major pharmaceutical companies.

(a) Tavist(R) is a registered trademark of Novartis Pharmaceuticals Corp.

Note: Except for historical information contained herein, this document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. These statements involve known and unknown risks and uncertainties that may cause the company's actual results or outcomes to be materially different from those anticipated and discussed herein. Further, the company operates in industries where securities may be volatile and may be influenced by regulatory and other factors beyond the company's control. Important factors that the company believes might cause such differences are discussed in the risk factors detailed in the company's most recent Form 10-KSB, dated Oct. 31, 1999, filed with the Securities and Exchange Commission; a copy of that Form 10-KSB is available from the company upon request. In assessing forward-looking statements contained herein, if any, reader is urged to carefully read all cautionary statements contained in that filing with the Securities and Exchange Commission.
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Publication:Business Wire
Date:Jun 13, 2000
Words:513
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