In conjunction with development partner Actavis (ACT -0.5%), Ironwood Pharmaceuticals (IRWD -0.7%) initiates a Phase 2 clinical trial (~240 patients) to assess the safety and efficacy of linaclotide for the treatment of adults with opioid-induced constipation (OIC). Data is expected in 2H 2015.
Linaclotide is currently FDA-approved for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation.
The FDA sends Sucampo Pharmaceuticals (SCMP -0.1%) a complete response letter (CRL) to its prior approval supplement (PAS) after its review of the revised Drug Master File (DMF) of R-Tech Ueno, Ltd. R-Tech revised its DMF when it relocated its manufacturing facility for Rescula (unoprostone isopropyl ophthalmic solution) to Nitto Medic Co. The FDA issues its CRL because previously cited deficiencies have not been corrected. Sucampo plans to resubmit its PAS in 2H 2014. It has an adequate supply of Rescula to service the U.S. market into Q1 2015.
Sucampo Pharmaceuticals (SCMP -3.3%) slips today, despite announcing earlier that it had achieved positive top-line results from two recently completed Phase 1a clinical trials of both cobiprostone and SPI-3608.
The studies tested the tolerability and pharmacokinetic profiles versus placebo of the two compounds, both of which were demonstrated to be generally well-tolerated in the tested populations.
SPI-3608 is being investigated for the treatment of mild to moderate lumbar spinal stenosis and may be investigated for additional indications in the future.
The next phase of development for SPI-3608 is expected to begin in the first quarter of 2014.
Data on cobiprostone showed that it induces mucosal barrier repair and prevents mucosal barrier damage, and the fact that it was well-tolerated in this study, the company says, is extremely encouraging.
The EMA grants orphan drug designation for Sucampo Pharmaceuticals' (SCMP) retinitis pigmentosa treatmentunoprostone isopropyl. The FDA has already given the product the same designation and an alternate formulation is FDA approved. (PR)
Sucampo Pharmaceuticals (SCMP) and its partner Takeda (TKPHF.PK) say AMITIZA has racked up a third indication as the FDA approves the drug for the treatment of opioid-induced constipation. Cantor Fitzgerald previously said AMITIZA could ultimately prove to be a major catalyst for shares of SCMP which are up a quick 13.6% premarket.
$SCMP looks very undervalued compare to its growth rate.
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Sucampo Pharmaceuticals, Inc. is a biopharmaceutical company engaged in research, development & sale of proprietary drugs based on ion channel activators known as prostones to treat gastrointestinal, neurologic, & oncology-based inflammatory disorders.