For Immediate Release
Date: September 2, 2011
Louisville, KY (September 2, 2011)US WorldMeds, LLC announced today that it has implemented a Co-Pay Assistance Program for MYOBLOC® (rimabotulintoxinB) Injection to help patients who qualify for financial support.
Please see Important Safety Information on next page and visit www.myobloc.com for the full Prescribing Information and Medication Guide.
"After last year's acquisition of Solstice Neurosciences, LLC," said Lee Warren, Chief Operating Officer the US WorldMeds, "our management team initiated an intense review of all patient programs available and concluded that co-pay assistance was an absolute must that should be added to our increasing portfolio of services."
Warren added, "As an ongoing commitment to assist health care providers and their patients, US WorldMeds is confident that this new Co-Pay Assistance Program will undoubtedly prove beneficial to many of the patients we serve. We know that in today's economy, some patients may be experiencing hardships and we encourage those who might qualify for financial assistance to contact us."
This new program is designed to assist eligible patients with actual out-of-pocket treatment costs for MYOBLOC (e.g., drug co-pay) as determined by the Co-Pay Assistance Program guidelines. The program provides patients with benefits that include a simplified application process, easy implementation, financial assistance to patients treated with MYOBLOC based on eligibility, and active support by Co-Pay Assistance Program advocates.
For more information about this program, call MYOBLOC Customer Service at 888-461-2255 option 3, 9:00 AM to 6:00 PM Eastern Time, Monday through Friday, or visit www.myobloc-reimbursement.com.
US WorldMeds is a Kentucky-based specialty pharmaceutical company that develops, licenses and commercializes unique medical therapies that address unmet patient needs. US WorldMeds' products include novel treatments for malignant hyperthermia, cervical dystonia and symptoms of opiate withdrawal.
MYOBLOC has a boxed warning related to the distant spread of toxin effect: The effects of MYOBLOC and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.
The most frequently reported adverse events with MYOBLOC are dry mouth, dysphagia, dyspepsia, and injection site pain. The vast majority of these adverse events were mild to moderate, temporary, self-resolving, and more common with higher doses. These adverse events may occur within the first week following treatment and may have a duration of several months. In controlled clinical trials, few patients (<1%) stopped treatment due to dry mouth or dysphagia. There is a reduced frequency of dry mouth and dysphagia reported with continued treatment. Dysphagia has commonly been reported by patients treated with all botulinum toxins for cervical dystonia.
Caution should be exercised when administering MYOBLOC to individuals with motor neuron disease (eg, amyotrophic lateral sclerosis), peripheral motor neuropathic diseases (eg, motor neuropathy) or neuromuscular junctional disorders (eg, myasthenia gravis or Lambert-Eaton syndrome). These patients may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC. In these patients, rare cases of dysphagia severe enough to cause aspiration pneumonia or to warrant the insertion of a gastric feeding tube have also been reported.
Coadministration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
MYOBLOC is a registered trademark of Solstice Neurosciences, LLC, a wholly-owned subsidiary of US WorldMeds, LLC.