by Susan Wells Courtney
More Data Needed for Oral Cladribine
On March 2, 2011, EMD Serono, Inc., makers of Cladribine Tablets (an oral formulation of cladribine for the treatment of MS), announced that the United States Food and Drug Administration (FDA) was not able to approve the application for Cladribine Tablets without additional information. According to EMD Serono, the FDA found substantial evidence of Cladribine Tablets' effectiveness as indicated by the CLARITY study (CLAdRIbine Tablets treating MS orallY).While the effectiveness was not in question, the FDA is looking for an improved understanding of safety risks and the overall benefit-risk profile of Cladribine.
EMD Serono notes that they remain committed to completing their ongoing studies with Cladribine Tablets and to continue to seek FDA approval of their drug. Three ongoing studies are nearing completion, and top-line results (the initial, primary outcomes of a study) are expected by the end of 2011 and in the first half of 2012. The safety data from these studies should provide valuable, additional safety data for the FDA to consider.
FDA Approves Nuedexta to treat Pseudobulbar Affect (PBA)
On October 29, 2010,Avanir Pharmaceuticals, Inc. announced the approval of Nuedexta™ by the Food and Drug Administration (FDA) for the treatment of pseudobulbar affect (PBA) associated with certain neurological conditions, including MS. PBA is characterized by uncontrolled, inappropriate, and/or exaggerated episodes of crying, laughing, or other emotional display. PBA occurs involuntarily with little or no stimulation to invoke such a response. It can greatly impact social situations and overall quality of life, both for the patient and his or her family.
Nuedexta is an oral drug in capsule form. Initially, a patient is given one capsule daily for the first seven days. Beginning on the eighth day, the medication is increased to the full dose of two capsules daily (one capsule every 12 hours). No one should take more than two capsules within a 24-hour period, and if a dose is missed, it will need to be skipped, as two doses should never be taken at the same time.
In studies with Nuedexta, episodes of excessive crying and laughing were significantly reduced in the treated group as compared to placebo, both in terms of frequency and severity. According to Avanir, the response to this drug is readily observable within a short time - often within the first week. In the most recent clinical trial (the STAR trial), about half of the patients with PBA experienced a complete remission of this symptom by the end of the study while taking Nuedexta. Scores on a scale measuring emotional lability (the Center for Neurologic Study-Lability Scale [CNS-LS]) significantly decreased. The approval of Nuedexta comes after 10 years of research and development.
MSAA Survey Reveals Surprising Results
(published online March 1, 2011)
The Multiple Sclerosis Association of America (MSAA) conducted an independent, online survey of almost 20,000 of its members in the fall of 2010. The purpose of this survey was to better understand the extent and impact of pseudobulbar affect (PBA) among people living with MS. The results were surprising in both areas.
A total of 5,229 people completed the online survey. Of these respondents, 2,504 or 48 percent reported experiencing symptoms of PBA based on their answers to a scientifically developed measurement scale (the CNS-LS). This percentage is higher than the estimated 10 to 15 percent of the MS population that has been cited as potentially being affected by PBA. Of the 2,504 who reported behaviors (experiences) associated with PBA, 2,389 identified themselves as having MS and an additional 115 care partners or family members completed the survey on behalf of a person with MS.
Our results suggest that PBA might be more widespread in the MS population than was previously thought. Additionally, the frequency of these episodes and their impact on daily life were also considerable.
|Last Updated on Tuesday, 29 January 2013 12:53|