STAXYN® - New Innovation in Erectile Dysfunction Helps Younger Men Rise to the Occasion

~Health Canada Approves STAXYN®, the First Orally Disintegrating Tablet at Roughly Half the Cost of Most ED Medications~

TORONTO, Aug. 29, 2011 /CNW/ - Today, Bayer Inc. announced the Health Canada approval of STAXYN® (vardenafil hydrochloride 10 mg), the first orally disintegrating tablet for the treatment of erectile dysfunction (ED) that lasts up to eight hours.  Now, for the first time in nearly a decade, younger Canadian men with ED have a new and effective treatment option that rapidly dissolves on the tongue, is roughly half the cost of most ED medications and fits their lifestyle needs.

"Physicians are increasingly seeing men in their 30s, 40s and early 50s with ED who have no obvious physical cause, such as diabetes, high cholesterol or hypertension, and it's actually stress acting as a trigger," said Dr. Gerald Brock, Professor in the Department of Surgery, Division of Urology at St. Joseph's Health Centre in London, Ontario.  "As a physician who commonly sees and treats these men, I am pleased that STAXYN is available for this patient population - it's a safe and effective option for men with ED, that dissolves quickly on the tongue and lasts up to eight hours when used as indicated."

Unlike men in their late 50s and 60s, research shows that younger ED patients (aged 35-55 years) attribute stress (59 per cent) as one of the main causes of their ED.1  These younger men who perceive their ED as temporary are proactive in seeking suitable treatment options for their condition.2

STAXYN has features that are appealing to the younger ED patient, including:

  • First orally disintegrating tablet that rapidly dissolves on the tongue within seconds;
  • Sex can be initiated for up to eight hours after taking STAXYN;
  • Available in Canada at roughly half the cost of most prescription ED medications per unit;
  • Comes in a sleek, black, pocket-sized slide-out package with four tablets;
  • STAXYN can be taken before or after a meal;
  • The efficacy of STAXYN is not affected by moderate amounts of alcohol.

Research shows that 43 per cent of ED medication users split their pills to save money;3,4 however, splitting pills can effect efficacy.  The affordability of STAXYN may address this behaviour.

"Unfortunately, splitting pills is a common practice among ED patients and is generally done to combat the lack of affordability of other ED treatments," said Dr. Francois Bénard, Associate Professor and Director of Urology, Saint-Luc Hospital, Montreal, Quebec.  "Now with STAXYN, my younger patients can have a treatment that works and meets their needs, without splitting pills."

Erectile dysfunction in Canada

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance.5 Approximately 152 million men worldwide6 and three-to-four million Canadian men suffer from ED.7 The number of men with ED is expected to more than double to 322 million worldwide by 2025.8 Despite the high prevalence of sexual dysfunction, experts estimate that only 30 per cent of men seek professional help and the percentage of those who actually receive treatment is even lower.9

About STAXYN®

STAXYN® is indicated for the treatment of erectile dysfunction (difficulties or inability to achieve or maintain penile erection sufficient for satisfactory sexual performance).

The overall efficacy and safety of vardenafil have been widely demonstrated in numerous clinical trials. STAXYN was tested in the Phase III multinational trials POTENT I and II (Pivotal phase III trial to investigate the efficacy and safety of STAXYN versus placebo in the treatment of men with ED: fixed-dose, double-blind, randomized multicentre trials). The POTENT II study was conducted in Canada, the United States, Mexico and Australia.

These pivotal studies compared the efficacy and safety of STAXYN with placebo after 12 weeks of treatment in a general population of men with ED. These two international twin studies were conducted with identical study design, enrolling a total of 701 men above the age of 18 years who had ED for more than six months.1  For both POTENT I and II studies, STAXYN was statistically superior to placebo for all primary {International Index of Erectile Function (IIEF-EF), erection sufficient for penetration (SEP2), and erection to successful intercourse (SEP3)} efficacy measures (all p<0.0001 versus placebo).

As with other PDE5 inhibitors co-administration of STAXYN with nitrates and nitric oxide donors is contraindicated. Concomitant use of STAXYN with indinavir, ritonavir, ketoconazole, itraconazole, erythromycin or clarithromycin is contraindicated, as they are potent inhibitors of CYP 3A4. Patients should be stable on alpha-blocker therapy before prescribing STAXYN.  Patients receiving alpha-blocker therapy should not use STAXYN as a starting dose.

Treatments for erectile dysfunction, including STAXYN, should generally not be used in men for whom sexual activity is not recommended because of their underlying cardiovascular status.

If a patient is taking STAXYN and experiences temporary or permanent loss, or change in vision in one or both eyes, he should stop taking STAXYN and call his doctor.  Sudden decrease or loss of hearing has been reported with the use of this class of drug (PDE5 inhibitors), including STAXYN.  If a patient experiences these symptoms, he should stop taking STAXYN and contact his doctor.

STAXYN contains Aspartame, a source of phenylalanine, and may be harmful for people with phenylketonuria.  A patient should talk to his doctor or pharmacist if he has phenylketonuria or an intolerance to sorbitol.

The most common adverse events observed in trials with STAXYN were headache (14.4%), flushing (7.6%), nasal congestion (3.1%), dyspepsia (2.8%), dizziness (2.3%), and back pain (2.0%).

Patients should refer to the Product Monograph for complete information.

About Bayer Inc.

Bayer Inc. (Bayer) is a Canadian subsidiary of Bayer AG, an international research-based group with core businesses in health care, crop science and innovative materials. Headquartered in Toronto, Ontario, Bayer Inc. operates the Bayer Group's HealthCare and MaterialScience businesses in Canada. Bayer CropScience Inc., headquartered in Calgary, Alberta operates as a separate legal entity in Canada.  Together, the companies play a vital role in improving the quality of life for Canadians - producing products that fight diseases, protecting crops and animals, and developing high-performance materials for applications in numerous areas of daily life. Canadian Bayer facilities include the Toronto headquarters and offices in Montréal and Calgary.

Bayer Inc. has approximately 800 employees across Canada and had sales of $827 million CDN in 2010.  Globally, the Bayer Group had sales of over 35 billion Euro in 2010.  Bayer Inc. invested approximately $36 million CDN in research and development in 2010. Worldwide, the Bayer Group spent the equivalent of over 3.1 billion Euro in 2010 in R&D. For more information, go to www.bayer.ca.

REFERENCES:

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1 Research Strategy Group Inc. "STAXYN Patient Research: Phase 2 Quantitative." July 4, 2011.  Slide 15.
2 Research Strategy Group Inc. "STAXYN Patient Research: Phase 2 Quantitative." July 4, 2011.  Slide 11 and 12.
3 Research Strategy Group Inc. "STAXYN Patient Research: Phase 2 Quantitative." July 4, 2011.  Slide 8.
4 Research Strategy Group Inc. "STAXYN Patient Research: Phase 2 Quantitative." July 4, 2011.  Slide 8.
5 Araugo et al.  Relation between the Psychosocial Risk Factors and Incident Erectile Dysfunction: Prospective Results from the Massachusetts Male Aging Study.  American Journal of Epidemiology 2000; 152, no.6: 533 - 541.
6 Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999; 84:50-56.
7 Canadian Male Sexual Health Council.  What is Erectile Dysfunction?  Accessed August 2, 2011.  http://www.cmshc.ca/Education0.php.
8 Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999; 84:50-56.
9 Shabsigh et al.  Sexual Medicine:  Drivers and barriers to seeking treatment for erectile dysfunction:  a comparison of six countries.  BJU International, 2004.
10 Sperling H. et al. Efficacy and Safety of an Orodispersible Vardenafil Formulation for the Treatment of Erectile Dysfunction in Elderly Men and Those with Underlying Conditions: An Integrated Analysis of Two Pivotal Trials. Journal of Sex Medicine. 2011; 8: 261-271.

For further information:

or to arrange an interview, please contact:

Rick Maddalena
GCI Group
416-486-7225
rick.maddalena@gcicanada.com
  Michael Kerr
Bayer Inc.
416-240-5958
michael.kerr@bayer.com