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

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New ED medication expected to be available by prescription later this year

Issued: 18 June 2010, Philadelphia, PA & Whitehouse Station, NJ – GlaxoSmithKline (NYSE: GSK) and Merck & Co., Inc. (NYSE: MRK) announced today the U.S. Food and Drug Administration (FDA) has approved STAXYN™ (vardenafil HCI), 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™(vardenafil HCl) orally disintegrating tablets

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

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.

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.

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).

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.

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.   

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.

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

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

Do not use STAXYN in patients on renal dialysis.

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.

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

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

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.

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

About LEVITRA ® (vardenafil HCl) tablets

LEVITRA is indicated for the treatment of erectile dysfunction

Selected Safety Information for LEVITRA

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

In men for whom sexual activity is not recommended because of their underlying cardiovascular status, any treatment for erectile dysfunction, including LEVITRA, generally should not be used.

LEVITRA is not recommended for patients with uncontrolled hypertension (>170/110 mmHg)

In patients taking certain CYP3A4 inhibitors (eg, ritonavir, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, erythromycin, and clarithromycin), lower doses of LEVITRA are recommended, and time between doses of LEVITRA may need to be extended. See prescribing information for dosing guidance.

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.

Caution is advised when PDE5 inhibitors, including LEVITRA, are used concomitantly with stable alpha-blocker therapy, because of the potential for significantly lowering blood pressure.

LEVITRA should not be used in men taking class IA or III antiarrhythmics or those with congenital QT syndrome.

Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) has been reported rarely postmarketing in temporal relationship with the use of PDE5 inhibitors, including LEVITRA. Sudden decrease or loss of hearing, sometimes with tinnitus and dizziness, also has been reported rarely in temporal association with the use of PDE5 inhibitors, including LEVITRA. It is not possible to determine if these events are related to PDE5 inhibitors or to other factors. Physicians should advise patients to stop use of PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden decrease or loss of vision or hearing.

In clinical trials, the most commonly reported adverse events with LEVITRA were headache, flushing, and rhinitis.

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

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. – 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.

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