Expert opinion on pharmacotherapy
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Expert Opin Pharmacother · Oct 2013
CommentOral BG-12 (dimethyl fumarate) for relapsing-remitting multiple sclerosis: a review of DEFINE and CONFIRM. Evaluation of: Gold R, Kappos L, Arnold D, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis. N Engl J Med 2012;367:1098-107; and Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis. N Engl J Med 2012;367:1087-97.
Multiple sclerosis (MS) is an autoimmune neurodegenerative disease of the central nervous system involving inflammation, chronic demyelination and axonal loss. MS affects more than 2 million people worldwide. ⋯ The combination of robust efficacy, ease of administration and established safety profile is unique to a new therapy in MS. Findings from the pivotal Phase III studies support BG-12 as a potential initial oral treatment for patients with RRMS or as an alternative to other currently available therapies.
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Expert Opin Pharmacother · Oct 2013
ReviewOmacetaxine mepesuccinate (synribo) - newly launched in chronic myeloid leukemia.
Omacetaxine mepesuccinate (formerly known as homoharringtonine [HHT]) is a natural alkaloid with significant anticancer activity partly through inhibition of protein synthesis and induction of apoptosis. Prior to the development of tyrosine kinase inhibitors (TKIs), HHT was the most active therapy in chronic myeloid leukemia (CML) after interferon failure. Subsequent trials showed that HHT and omacetaxine are active in patients failing several TKIs or carrying the T315I mutation. ⋯ A sizable number of patients with CML will develop TKI resistance, frequently through the acquisition of BCR-ABL1 kinase domain mutations. Omacetaxine is active in patients with CML after failure to multiple TKIs and in those carrying the T315I mutation, which is highly resistant to all FDA-approved TKIs except for ponatinib. Both ponatinib and omacetaxine have been recently approved by the FDA and represent useful treatment options for patients with CML who failed several TKIs and/or acquired the T315I mutation. The development of an oral formulation of omacetaxine would greatly facilitate its use and provide an attractive option for TKI-based combinatorial strategies.
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Expert Opin Pharmacother · Oct 2013
ReviewLinaclotide: a novel compound for the treatment of irritable bowel syndrome with constipation.
Irritable Bowel Syndrome with constipation (IBS-C) is associated with abdominal pain and infrequent spontaneous bowel movements. Patients with Chronic Idiopathic Constipation do not have abdominal pain as a predominant symptom. Linaclotide represents a new class of medication approved in the USA for both of these common conditions. Linaclotide is approved for IBS-C only in the EU. The only other medication approved at this time for IBS-C is lubiprostone. ⋯ Linaclotide is superior to placebo for the treatment of both IBS-C and Chronic Idiopathic Constipation. The drug has minimal systemic bioavailability and a favorable safety profile. For IBS-C, it is appropriate as a first-line prescription treatment. For Chronic Idiopathic Constipation, osmotic or stimulant laxatives should be tried prior to using linaclotide due to their considerable lower cost.