|Posted by Moderator-JB ® , Feb 12,2001,10:08||Archive|
I am writing to tell you about MYOBLOCTM (Botulinum Toxin Type B) Injectable Solution, a new botulinum toxin therapy. MYOBLOC has been shown to be effective in patients with cervical dystonia (also known as spasmodic torticollis) to reduce neck pain and allow for more normal head positioning.
In clinical studies, patients treated with MYOBLOC showed a greater reduction in neck
pain and in abnormal flead position versus those patients who had received inactive drug (placebo). In patients who responded, the effect of MYOBLOC typically lasted 3 to 4 months. The most frequent side effects reported with MYOBLOC are dry mouth, difficulty
swallowing, upset stomach, and pain at the injection site. These side effects are generally mild to moderate, temporary, clear up on their own, and more common with higher doses.
MYOBLOC is the only botulinum toxin therapy available in a ready-to-use solution that requires only refrigeration storage. It can be stored in your doctor’s refrigerator for up 21 months in unopened vials. In addition MYOBLOC is available in three convenient dosing volumes, which allows your doctor to customize therapy to your individual needs.
If you begin therapy with MYOBLOC, you will also discover another important benefit the Solutions Program~-a patient support program specially created for patients who are receiving treatment with MYOBLOC. The Solutions Program has been designed to create an ongoing dialogue with patients like you. Once you enroll in the Solutions Program, you
will begin to enjoy the many advantages of membership. You’ll receive educational materials about cervical dystonia and about therapy with MYOBLOC. You’ll also be invited to participate in surveys designed to give us a better ~ of you and your needs. Patients being treated with MYOBLOC can enroll in the Solutions Program by calling 1-888-GO-I-
CALL ~ by completing the Enrollment Questionnaire enclosed with this letter. Please be assured That The information you provide will be used by us for the sole purpose of making the Solutions Program beneficial to you.
We are happy to bring you this exciting news and hope that you will speak to your doctor to find out if MYOBLOC is right for you.
Christopher F. O’Brien, MD
Vice President, Medical Affairs
PS: For further information about MYOBLOC, visit our website at www.MYOBLOC.com
MYOBLOC is indicated for the treatment of patients with cervical dystonia to reduce neck pain and The severity of abnormal head position associated with cervical dystonia
The most frequently reported adverse events associated wrth MYOBLOC in all studies were dry mouth, dysphagia, dyspepsia, and injection site pain. These adverse events are generally mild to moderate, transient, self-resolving, and more common with higher doses.
Please see accompanying full Prescribing In formation
Distributed by Elan Pharmaceuticals
MYOBLOC and the MYOBLOC logo are trademarks of Elan Pharmaceuticals,
MBC-835 January 2001
800 Gateway Boulevard South San Francisco, CA 94080