KALAMAZOO, Mich. Aug. 30 1995 -- The Upjohn Company (NYSE: UPJ) today announced the availability of Caverject Sterile Powder (alprostadil for injection) for the diagnosis and treatment of erectile dysfunction, commonly known as male impotence. It is the first prescription medication cleared for marketing as a treatment for erectile dysfunction. Caverject received FDA clearance on July 6.
The product has gained marketing clearance in thirty countries, including the United Kingdom, France, Spain and Italy. Additional registration applications have been filed throughout the world.
Erectile dysfunction is the consistent inability to attain and maintain a penile erection that is satisfactory for intercourse. The condition affects an estimated 10 to 20 million men in the United States.
"The introduction of Caverject is an important development for the millions of men who suffer from impotence," said Ley Smith, President and Chief Operating Officer. "Caverject offers men and their partners hope for a problem for which there was previously no approved medication."
Impotence occurs with greater frequency after age 40, although it is not inevitable with aging. The condition can result from complications of chronic conditions such as coronary artery disease, high cholesterol levels, high blood pressure and diabetes mellitus. Side effects of surgery, medication and psychological influences are also associated with impotence, as are lifestyle factors such as a high-fat diet, drug abuse, excessive alcohol consumption and smoking.
How Caverject Works
Caverject is administered via small-needle injection into an area of the penis known as the corpus cavernosum. It works by relaxing smooth muscle tissue which, in turn, enhances blood flow to the penis, creating an erection. The drug is indicated for the treatment of erectile dysfunction whether the cause is neurological, vascular, psychological or of mixed origin. Patients selected for treatment with Caverject receive initial injections from medically-trained personnel to determine optimum dosing. Caverject can be administered by the patient once he has been trained to self-inject.
Approximately 200 reports exist in published literature on self- injection therapy with alprostadil. Results from clinical trials showed that more than 80 percent of patients diagnosed with erectile dysfunction who used Caverject experienced an erection.
Caverject and the Patient
According to J. Francois Eid, M.D., director of the Erectile Dysfunction Unit at The New York Hospital-Cornell Medical Center, the availability of Caverject could have a significant impact on the lives of patients and their partners.
"For many men, impotence is a source of extreme emotional frustration, embarrassment and loss of self-esteem," said Eid, who conducted clinical trials with the drug for Upjohn. "Caverject represents new hope for the many impotent men and their partners currently suffering in silence. It also represents an important new treatment option for those impotent men not satisfied with their current therapy."
The Origins of Caverject
Caverject contains prostaglandin E1 (alprostadil), a vasoactive agent that, in a different formulation, has been used as a pre-surgical treatment for infants with congenital heart defects. Prostaglandins occur naturally in human tissues and fluids and play a role in the mechanism of natural erection. Caverject is administered via injection into the penis, using a syringe with a small needle.
In clinical studies, the most common side effect of Caverject was penile pain (37 percent). Other less common side effects include injection site bleeding (5 percent), prolonged erection of four to six hours (4 percent), and fibrosis (3 percent, with one, 18-month study recording a rate of 7.8 percent). The incidence of priapism, an erection that lasts more than six hours, was 0.4 percent.
Caverject is a prescription medication; interested patients should see their doctor or another physician familiar with treating impotence for a physical examination and diagnosis.
Diagnosis of impotence requires a medical and sexual history of the patient followed by a physical exam and basic laboratory tests.
Caverject is not recommended for patients with a known allergy to the drug and for patients who have conditions that might predispose them to prolonged erection, such as sickle cell anemia or trait, leukemia, multiple myeloma or abnormal anatomical deformation of the penis.
Consumers interested in more information on erectile dysfunction can call 800-727-8984. Callers will receive a list of qualified doctors in their area, as well as a packet of non-product-specific information on the causes and treatments of erectile dysfunction.
The Upjohn Company is a worldwide, research-based provider of human health care products, animal health products and specialty chemicals. Headquartered in Kalamazoo, Mich., the company has been dedicated to improving health and nutrition for more than a century.
CONTACT: Daniel Watts of Upjohn, 616-323-6369; or Kelly Dencker of Manning,Selvage & Lee, 212-213-7769
All contents Copyright (c) 1995 P\S\L Consulting Group Inc. All rights reserved.