|Shionogi’s Nitrolingual® Pumpspray is Available for Angina Pectoris Patients|
|ATLANTA (April 1, 2010) – Shionogi Pharma, Inc. today reminds healthcare providers that its Nitrolingual® Pumpspray (nitroglycerin lingual spray), approved by the U.S. Food and Drug Administration (FDA) in 2002, is a viable alternative to nitroglycerin tablets and can be considered by healthcare professionals looking for treatment options for the many patients currently in need. |
As referenced in an FDA March 16, 2010, press release, the FDA notified certain manufacturers of nitroglycerin tablets to cease distribution. The FDA stated, "The unapproved nitroglycerin tablets have not been proven safe and effective, and the FDA has not reviewed the quality and labeling of these products.”
Shionogi markets Nitrolingual® Pumpspray which is administered with one spray onto or under the tongue.
Key features of Nitrolingual Pumpspray include:
The Pumpspray Promise and Money Back Guarantee
Maintenance of stability and potency
- A long shelf life with stability up to 24 months from time of manufacture
- No concerns regarding loss of potency due to light, moisture, or handling
- In one study, 69% of patients using nitroglycerin lingual spray reported relief within 60 seconds versus 38% of patients who used nitroglycerin tablets
- Ιn the same study, more patients reported no headache with spray versus tablets (58% vs 39%).
Shionogi Pharma, Inc. offers the Pumpspray Money Back Guarantee, which enables patients to try Nitrolingual Pumpspray – knowing that if they are not completely satisfied, the Company will reimburse them for the out-of-pocket amount they paid for the prescription. For more information on the Pumpspray Promise and Money Back Guarantee visit www.nitrops.com.
Nitrolingual Pumpspray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.
Important Safety Information
Nitrolingual Pumpspray should not be used while taking phosphodiesterase inhibitors which are used for treatment of erectile dysfunction. Nitrolingual Pumpspray should be used with caution if patients have low systolic blood pressure, are undergoing diuretic therapy or show hypersensitivity to this and other nitrates or nitrites. Headache is the most commonly reported side effect with nitroglycerin. Patients may also experience episodes of dizziness, weakness, and other related side effects.
For full prescribing information visit https://www.nitrops.com/nitrops/scnit_web_10_pi.jsp.
About Angina Pectoris
Angina pectoris (a symptom of a condition called myocardial ischemia) is the medical term for chest pain or discomfort usually due to coronary artery disease. Almost 9 million people suffer from angina pectoris in the United States.
Angina may be triggered by an increase in physical activity—like running or shoveling snow. It may happen during exercise or during periods of mental or emotional stress, or even when a person is resting comfortably. Angina can happen frequently or only once in a while. Angina causes a feeling of uncomfortable pressure, fullness, squeezing or pain in the center of the chest and/or discomfort in the neck, jaw, shoulder, back or arm. Sometimes angina can be accompanied by shortness of breath, nausea, dizziness or tiredness. Some people may break into a cold sweat or feel their heart pounding. The symptoms of angina are due to the fact that the heart muscle is not getting as much blood or oxygen as it needs, usually because the arteries of the heart have become narrowed or blocked. If you feel you may be at risk for angina, or have experienced chest pains, it is important to discuss your symptoms with your healthcare professional.
About Shionogi & Co., Ltd.
Headquartered in Osaka, Japan, Shionogi & Co., Ltd. is a major research-driven pharmaceutical company dedicated to placing the highest value on patients. Shionogi’s Research and Development currently targets three therapeutic areas: Infectious Diseases, Pain, and Metabolic Syndrome. The Company has provided such innovative medicines as Crestor and Doripenem, which have been successfully delivered to millions of patients. In addition, Shionogi is engaged in new research areas such as allergy and cancer. Contributing to the health of patients around the world through development in these therapeutic areas is Shionogi’s primary goal. For more details, please visit www.shionogi.co.jp. For more information on Shionogi Pharma, Inc. based in Atlanta, Georgia, please visit www.shionogipharma.com.
Forward Looking Statements
This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, unavailability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.
Shionogi Pharma, Inc.
Joseph T Schepers
HealthStar Public Relations