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.