Latest News - Phase 3/4 Trials

Tuesday, June 27, 2017 | Epilepsy & Seizure Disorders, Phase 3/4 Trials

Low-Dose Fenfluramine Granted Orphan Status for LGS

The FDA has granted orphan drug designation to ZX008 (Zogenix), an investigational treatment for Lennox Gastaut Syndrome (LGS). Zogenix will initiate a Phase 3 clinical trial in LGS in second half of …

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Wednesday, June 14, 2017 | Movement Disorders, Phase 3/4 Trials, Research and Publications

Phase 3 Results Published for Investigational Levodopa-Induced Dyskinesia Treatment

Results from the Phase 3 EASE LID clinical trial, published online in JAMA Neurology, show that the investigational ADS-5102 (amantadine, Adamas Pharmaceuticals) reduces levodopa-induced dyskinesia (L…

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Tuesday, June 13, 2017 | Pain & Headache, Phase 3/4 Trials, Research and Publications

AHS 2017: Amgen’s CGRP Inhibitor Reduces Migraine Days

New Phase 2 data show that Amgen’s investigational investigational CGRP inhibitor erenumab is effective at preventing migraine in patients experiencing 15 or more migraine days per month. In a s…

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Thursday, June 08, 2017 | Pain & Headache, Phase 3/4 Trials, Research and Publications

AHS 2017 Meeting: Prochlorperazine More Effective than Hydromorphone for Acute Migraine

A new comparative study presented at the American Headache Society Annual Meeting in Boston shows that that, in patients who visit the emergency department for acute migraine treatment, prochorperazin…

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Friday, May 12, 2017 | Pain & Headache, Phase 3/4 Trials, Research and Publications

Lilly’s Investigational Monoclonal Antibody for Migraine Scores Positive Phase 3 Results

New Phase 3 data suggest that Eli Lilly’s investigational monoclonal antibody galcanezumab may significantly reduce the number of monthly migraine headache days. In the EVOLVE-1 study, pati…

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Tuesday, April 04, 2017 | FDA Approval/Clearance, Movement Disorders, Neuromuscular & Immune Disorders, Phase 3/4 Trials

New Therapy for Chorea Associated with Huntington’s Disease Wins FDA Approval

The FDA approved Austedo (deutetrabenazine, Teva Pharmaceuticals) tablets for the treatment of chorea associated with Huntington’s disease (HD), making it just the second product approved for th…

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Tuesday, March 28, 2017 | Clinical Trials, FDA Approval/Clearance, Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications, Genentech, Roche

Ocrevus Receives FDA Greenlight for Relapsing, Primary Progressive Forms of Multiple Sclerosis

The FDA has approved Ocrevus (ocrelizumab, Roche/Genentech) for the treatment of both relapsing and primary progressive forms of multiple sclerosis. Ocrelizumab is a humanized antibody that …

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Friday, February 10, 2017 | Movement Disorders, Phase 3/4 Trials

Inhaled Levodopa Impresses in Treating Parkinson’s OFF Periods in Phase 3 Study

New phase 3 data suggests that the experimental inhaled levodopa, CVT-301 (Acorda Therapeutics), may offer significant improvement in motor function in individuals with Parkinson’s disease exper…

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Thursday, January 26, 2017 | Phase 3/4 Trials, Research and Publications, Sleep

Investigational Narcolepsy Agent Found Effective for Severely Affected Patients with Cataplexy in Phase 3 Study

Results from a phase 3 controlled trial show that pitolisant (Wakix, Bioproject Pharma) may be efficacious in severely affected narcoleptic patients with cataplexy. Pitolisant is a highly-selective hi…

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Wednesday, January 04, 2017 | Neuromuscular & Immune Disorders, Phase 3/4 Trials, Research and Publications, Genentech

Newly Published Phase 3 Data Boost Efficacy Profile of Ocrevus in Primary Progressive and Relapsing MS

As the FDA continues its review of the Biologics License Application (BLA) for Genentech’s Ocrevus (ocrelizumab), key phase 3 findings reviewing the agent’s safety and efficacy in relapsin…

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Friday, December 09, 2016 | Epilepsy & Seizure Disorders, Phase 3/4 Trials, Research and Publications

NeuroPace Unveils New Long-Term Data for Its RNS System

At the recent American Epilepsy Society Annual Meeting in Houston, NeuroPace shared new long-term data for its RNS System for the treatment of partial-onset seizure. The RNS System monitors and respon…

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Thursday, December 08, 2016 | Epilepsy & Seizure Disorders, Phase 3/4 Trials, Research and Publications

Reflecting on New Phase 3 Epidiolex Data, GW Pharmaceuticals CEO Emphasizes Education About Cannabidiol

Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, shared phase 3 data in poster presentations at the recent American Epilepsy Society Annual Meeting showing that it’s investigational ca…

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Wednesday, December 07, 2016 | Epilepsy & Seizure Disorders, Phase 3/4 Trials, Research and Publications

AES 2016: Sunovion Launching Phase 4 Study of Aptiom Using Wearable Technology to Detect Seizure Activity

At the recent American Epilepsy Society Annual Meeting in Houston, Sunovion revealed that will soon initiate enrollment for a Phase 4 clinical study (Study 093-701) evaluating the use of the Embrace w…

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Thursday, December 01, 2016 | Epilepsy & Seizure Disorders, Phase 3/4 Trials, Pfizer

Adjunctive Treatment with Lyrica Found to Reduce Seizure Frequency in Pediatric Epilepsy

New phase 3 results show that Lyrica (pregabalin, Pfizer) Capsules CV is an effective adjunctive therapy for patients with epilepsy between the ages of four and 16 years of age. Specifically, the resu…

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Thursday, November 17, 2016 | Pain & Headache, Phase 3/4 Trials, Phase 3/4 Trials, Research and Publications

Investigational Biologic for the Treatment of Migraine Shows Promise in Phase 3 Data

New Phase 3 trial results suggest that Amgen’s investigational biologic agent erenumab may be effective at reducing migraines. Erenumab was specifically designed to prevent migraine by bloc…

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