Second phase-3 study of TC-5214 did not meet primary endpoint
WINSTON-SALEM, N.C. — AstraZeneca and Targacept released results of the second of four phase-3 clinical trials that investigated the efficacy and tolerability of a drug that could serve as an adjunct therapy to major depressive disorder patients that had an inadequate response to initial antidepressant therapies.
The drug makers noted that the study did not meet its primary endpoint of change after eight weeks of treatment with TC-5214, compared with placebo. In this study, TC-5214 overall was well tolerated in the second study of the Renaissance program and showed an adverse event profile "generally consistent" with prior clinical trials of TC-5214.
The study results were in line with the first Renaissance study conducted by AstraZeneca and Targacept.
The two remaining efficacy studies in the program for TC-5214 are fixed dose trials, the companies noted.
Upsher-Smith launches women’s health portal
MAPLE GROVE, Minn. — Upsher-Smith has launched an online portal for advanced-practice clinicians interested in women’s health, the company said.
Clinicians Corner provides nurse practitioners, physician assistants, nurses and midwives with resources and educational materials.
"Upsher-Smith recognizes the valuable role advanced-practice clinicians play in women’s health care," Upsher-Smith VP marketing Jim Hughes said. "Clinicians Corner is a trusted resource and one-of-a-kind educational community for busy clinicians, with direct, focused information tailored specifically to their practice."
Ulcerative colitis market to hit $3 billion by 2020
BURLINGTON, Mass. — The market for drugs to treat ulcerative colitis will increase from 2010’s $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.
Key factors driving the market will include uptake of Humira (adalimumab), made by Abbott and Eisai, and Simponi (golimumab), made by Johnson & Johnson and Merck, as well as drugs currently under development, like Millennium’s vedolizumab and Pfizer’s tofacitinib. Markets included in the analysis were the United States, Germany, France, Italy, Spain, Japan and the United Kingdom.
"Currently in phase-3 of development for moderate to severe ulcerative colitis, but with scant robust clinical data at present to confirm positive phase-2 results, vedolizumab and tofacitinib will likely extend the treatment algorithm by offering — for the first time — additional lines of therapy for patients with inadequate response to the [tumor necrosis factor]-alpha inhibitors," Decision Resources analyst Kathrina Quinn said.