Merck & Co, Inc announced today that the US Food and Medicate Administration (FDA) has approved SINGULAIR(R) (montelukast sodium) for the relief of symptoms of perennial allergic rhinitis (PAR), or indoor allergies, in adults and children six months of time eon and older. A convenient once-a-date tablet, SINGULAIR has been proven to help relieve a wide-ranging range of indoor and open-air allergy symptoms fitting for up to 24 hours.
“Allergic rhinitis is one of the most common allergic conditions today, with nearly 50 million people in the Merged States suffering some form of the condition,” said Gailen Marshall Jr., M.D., Ph.D., director of the Set of Clinical Immunology and Allergy at the University of Mississippi Medical Center in Jackson, MS. “Experts be undergoing estimated that 55 to 80 percent of these patients suffer from perennial, or year heat, allergic rhinitis which is commonly triggered by indoor allergens such as dust, pet dander or mold. The acceptance of SINGULAIR for the replacement of symptoms of perennial allergic rhinitis provides healthcare providers with a new, competent option to avoid bring relief to patients who suffer from indoor allergies and for whom SINGULAIR is nick.”
SINGULAIR, which was approved for the treatment of the symptoms of seasonal allergic rhinitus (SAR) in 2003, is another from most oral allergy medications, which block histamine, in that it blocks leukotrienes, an important contributor to allergy symptoms. SINGULAIR is the only medication indicated for allergic rhinitis that specifically targets this particular underlying contributor to allergy symptoms. SINGULAIR is approved for SAR in adults and children two years and older, and for WRETCHED in adults and children six months and older. With a view treatment of symptoms of allergic rhinitis, SINGULAIR is available in tablet acquire for adults (10 mg), as a cherry-chewable writing- (4 or 5 mg) fitting for children aged two to 14 years and in oral granules (4 mg) over the extent of children six months to five years.
SINGULAIR helps relieve a broad range of indoor and outdoor allergy symptoms
In separate clinical trials of PAR and SAR, SINGULAIR (10 mg) has provided significantly greater symbolic of relief compared to placebo. The efficacy of SINGULAIR for treatment of PAR was evaluated in two randomized, double-dense, placebo controlled studies in patients mature 15 to 82 years with NOT UP TO SNUFF. In one of these studies, SINGULAIR demonstrated effectiveness in improving daytime nasal symptoms score, the primary endpoint, measured as the run-of-the-mill of individualistic scores fit nasal congestion, runny nose and sneezing.
The efficacy of SINGULAIR allowing for regarding treatment of symptoms of SAR was previously established in placebo and active-controlled clinical studies of patients age 15 to 82 years. In these studies, SINGULAIR demonstrated effectiveness in improving daytime nasal symptoms score, the primary endpoint, regulated as the normally of individual scores for nasal congestion, runny nose, nasal itching and sneezing.
Protection profile of SINGULAIR in allergic rhinitis studies nearly the same to that seen with placebo
In clinical studies for both SAR and NORMAL, SINGULAIR was generally proper tolerated with a aegis utilize nearly the same to that of placebo for both children and adults. The incidence of sleepiness was similar to placebo in all studies for adults and adolescents 15 years of time eon and older with SAR and PAR. In these studies, the most a lot reported side effects included headache, ear infection, dangerous throat and characters upper class respiratory infection. These events varied by age, and were reported at a frequency greater than or equal to two percent, and at an incidence greater than placebo in either the SAR or PAR studies.
Important facts about SINGULAIR for treatment of asthma
SINGULAIR is also indicated fitting for the prevention and chronic treatment of asthma in adults and pediatric patients 12 months and older. The dislike of SINGULAIR for asthma may not rub out the necessary on account of inhaled or oral corticosteroids. Patients should be advised to cause SINGULAIR daily as prescribed requite when they force no symptoms, as well as during periods of worsening asthma, and to connection their health care provider if their asthma is not well controlled. SINGULAIR should not be used for the wildly remission of acute asthma attacks or used alone to critique and manage asthma made worse by exercise. Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-riotous agents while irresistible SINGULAIR.
In clinical studies for asthma, side effects in adults and children winsome SINGULAIR were on the whole mild and in the main did not induce patients to discontinue remedial programme. The most commonly reported side effects diverse by mature and included headache, ear infection, sore throat and power respiratory infection.
Around allergic rhinitis
Allergic rhinitis, an sore of the mucous membranes of the nose due to allergens, is one of the most cliched allergic conditions in the U.S., affecting close to 50 million Americans. Allergic rhinitis is classified as either seasonal or perennial depending upon the type of trigger and duration of symptoms. SAR symptoms occur in the spring, summer and/or early fall and are triggered by outdoor allergens such as airborne tree, stool-pigeon and weed pollens while PAR is usually persistent and continuing with symptoms occurring year-round and is commonly associated with indoor allergens such as dust mites, animal dander and/or mold spores. Symptoms of allergic rhinitis may contain runny nose, nasal itching, sneezing, watery eyes and nasal congestion.
About Merck
Merck & Co., Inc. is a far-reaching research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 restorative categories. The players devotes extensive efforts to strengthen access to medicines through far-reaching programs that not alone award Merck medicines but cure deliver them to the people who need them. Merck also publishes unbiased fettle information as a not-for-profit service. For more report, visit http://www.merck.com.
Impertinent-Looking Expression
This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Revise Act of 1995. These statements catch up in risks and uncertainties, which may induce results to differ greatly from those set forth in the statements. The further-looking statements may include statements regarding product event, product potential or financial scene. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no duty to publicly update any forward-looking statement, whether as a upshot of novel information, to be to come events, or way. Forward-looking statements in this correspondents release should be evaluated together with the many uncertainties that pretend to Merck’s business, particularly those mentioned in the cautionary statements in Ingredient 1 of Merck’s Form 10-K concerning the year ended Dec. 31, 2004, and in its periodic reports on Form 10-Q and Form 8-K which the company incorporates by pertinence.
SINGULAIR(R) (montelukast sodium) is a registered trademark of Merck & Co., Inc.
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