FDA approves Staxyn

FDA approves Staxyn (vardenafil HCl) orally disintegrating tablets for erectile dysfunction (ED)

Philadelphia, PA & Whitehouse Station, NJ June 18, 2010 – GlaxoSmithKline and Merck & Co., Inc. announced today the U.S. Food and Drug Administration (FDA) has approved Staxyn (vardenafil HCl), an orally disintegrating tablet indicated for the treatment of erectile dysfunction (ED).

Staxyn disintegrates on the tongue without liquid. Via a licensing arrangement with Bayer Healthcare Pharmaceuticals, Staxyn will be exclusively marketed in the U.S. by GSK and Merck. GSK and Merck expect to make the medicine available by prescription later this year.

Selected Safety Information for Staxyn

Contraindications

Administration of Staxyn with nitrates and nitric oxide donors is contraindicated.

Cardiovascular Effects

Treatment for ED, including Staxyn, should not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status. There are no controlled clinical data on the safety or efficacy of vardenafil in the following patients; and therefore its use is not recommended until further information is available: unstable angina; hypotension (resting systolic blood pressure of <90 mmHg); uncontrolled hypertension (>170/110 mmHg); recent history of stroke, life-threatening arrhythmia, or myocardial infarction (within the last 6 months); severe cardiac failure.

Potential for Drug Interactions with Potent or Moderate CYP3A4 Inhibitors

Do not use Staxyn with moderate and potent CYP3A4 inhibitors (eg, erythromycin, grapefruit juice, clarithromycin, ketoconazole, itraconazole, indinavir, saquinavir, atazanavir, ritonavir) as co-administration will result in significant increases in plasma vardenafil concentrations.

Risk of Priapism

As there have been infrequent reports of prolonged erections lasting more than 4 hours or priapism with all ED treatments in this drug class, patients should be advised to seek immediate medical attention should these occur. Staxyn should be used with caution by patients with anatomical deformations of the penis (such as angulation, cavernosal fibrosis, or Peyronie’s disease) or by patients who have conditions that predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).

Effects on the Eye

Physicians should advise patients to stop use of all PDE5 inhibitors, including Staxyn, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic Neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post marketing in temporal relationship with the use of all PDE5 inhibitors. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affect by use of vasodilators such as PDE5 inhibitors.

Staxyn has not been evaluated in patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, therefore its use is not recommended until further information is available in those patients.

Sudden Hearing Loss

Physicians should advise patients to stop taking all PDE5 inhibitors, including Staxyn and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including vardenafil.

Alpha-Blockers

Patients taking alpha-blockers should not initiate vardenafil therapy with Staxyn. Patients treated with alpha-blockers who have previously used vardenafil film-coated tablets may be switched to Staxyn at the advice of their healthcare provider.

Caution is advised when PDE5 inhibitors are co-administered with alpha-blockers therapy. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension.

Congenital or Acquired QT Prolongation

Patients with congenital QT syndrome or taking class IA or III antiarrhythmics should avoid using Staxyn.

Hepatic Impairment

Do not use Staxyn in patients with moderate or severe hepatic impairment.

Renal Impairment

Do not use Staxyn in patients on renal dialysis.

Effects on Bleeding

Staxyn has not been administered to patients with bleeding disorders or significant active peptic ulcerations. Therefore, Staxyn should be administered to these patients after careful benefit-risk assessment.

Phenylketonurics

Each Staxyn tablet contains 1.01 mg phenylalanine per tablet, which could be harmful for patients with phenylketonuria.

Fructose Intolerance

Staxyn contains sorbitol. Patients with rare hereditary problems of fructose intolerance should not take Staxyn.

Dosing Information

Staxyn is not interchangeable with vardenafil 10mg film-coated tablets (Levitra). Staxyn provides higher systemic exposure compared to vardenafil 10mg film-coated tablets (Levitra).

The maximum dosing frequency is one Staxyn tablet per day.

Most Common Adverse Reactions

In clinical trials, the most commonly reported adverse events with Staxyn were headache, flushing, nasal congestion dyspepsia, dizziness and back pain.

For further information, including complete Prescribing Information, please call 919-483-2839.

GlaxoSmithKline

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.

Merck & Co., Inc.

Merck & Co., Inc. – Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. Merck. Be well. For more information, visit www.merck.com.

GlaxoSmithKline Enquiries:

Media enquiries:
Rob Perry
(919) 483 2839
Sarah Alspach
(919) 483 2839

Analyst/Investor enquiries:
Tom Curry
(215) 751 5419
Jen Hill Baxter
(215) 751 7002

GlaxoSmithKline cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the ‘Business Review’ in GSK's Annual Report on Form 20-F for 2009.

Merck Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation; the risk that the businesses will not be integrated successfully; disruption from the merger making it more difficult to maintain business and operational relationships; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; the risk of new and changing regulation and health policies in the U.S. and internationally and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2009 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Posted: June 2010

Staxyn (vardenafil) FDA Approval History

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