BC Week In Review | Sep 7, 2018
Clinical News

Setback for Sunovion's dasotraline in ADHD

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said it received a complete response letter for dasotraline (SEP-225289) to treat ADHD. The company said FDA indicated the need for more efficacy...
BC Week In Review | Aug 3, 2018
Clinical News

Sunovion's high-dose dasotraline meets primary in Phase III for binge eating disorder

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said the once-daily 6 mg dose of dasotraline (SEP-225289) met the primary endpoint of reducing the number of binge days, defined as days...
BC Week In Review | Sep 29, 2017
Clinical News

Sunovion submits NDA for dasotraline in ADHD

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) submitted an NDA to FDA for dasotraline (SEP-225289) to treat ADHD. The dopamine and norepinephrine reuptake inhibitor (DNRI) is also in Phase III...
BC Week In Review | Feb 23, 2017
Clinical News

Dasotraline: Additional Ph II/III SEP360-202 data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported additional data from the double-blind, U.S. Phase II/III SEP360-202 trial in 342 ADHD patients ages 6-12 showing that once-daily 4 mg dasotraline improved mean ADHD-RS-IV Home Version total...
BC Week In Review | Jan 20, 2017
Clinical News

Dasotraline: Ph III SEP360-301 data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported top-line data from the double-blind, U.S. Phase III SEP360-301 trial in about 636 adults with ADHD showing that once-daily 4 and 6 mg doses of dasotraline both missed...
BC Week In Review | Jan 20, 2017
Clinical News

Dasotraline: Ph II/III SEP360-221 data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported top-line data from the double-blind, U.S. Phase II/III SEP360-221 trial in about 319 patients ages 18-55 with moderate to severe binge eating disorder showing that flexible dosing with...
BC Week In Review | Sep 26, 2016
Clinical News

Dasotraline: Phase II/III data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported top-line data from the double-blind, U.S. Phase II/III SEP360-202 trial in 342 ADHD patients ages 6-12 showing that once-daily 4 mg dasotraline met the primary endpoint of improving...
BC Week In Review | Feb 15, 2016
Clinical News

Dasotraline: Phase I data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported data from a double-blind, double-dummy, placebo- and active-controlled, 6-way crossover, Canadian Phase I human abuse liability trial in 48 recreational stimulant users who had specific experience with cocaine...
BC Week In Review | Dec 22, 2014
Clinical News

Dasotraline: Phase II data

Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary reported data from a double-blind, U.S. Phase II trial in 341 adults with ADHD showing that once-daily 8 mg dasotraline met the primary endpoint of improving ADHD-RS-IV total score...
BioCentury | Oct 5, 2009
Finance

3Q Approvals/3Q Setbacks

3Q Approvals/3Q Setbacks Company Approval Allos Therapeutics Inc. (NASDAQ:ALTH) FDA grants accelerated approval of Folotyn pralatrexate to treat relapsed or refractory peripheral T cell lymphoma (PTCL) Anika Therapeutics Inc. (NASDAQ:ANIK) Canada approves Monovisc to treat...
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