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Wired News – Biohaven Pharmaceutical Shares Positive Results From Bioequivalence Study With Sublingual BHV-0223 Zydis Orally Dissolving Tablet

LONDON, UK / ACCESSWIRE / January 11, 2018 / Active-Investors.com has just released a free research report on Biohaven Pharmaceutical Holding Co. Ltd (NYSE: BHVN) ("Biohaven"). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=BHVN as the Company's latest news hit the wire. On January 09, 2018, the Company, a clinical-stage biopharmaceutical organization with a portfolio of innovative, late-stage product candidates for neurological diseases and rare disorders, reported positive results from its bioequivalence study with BHV-0223, which is an innovative sublingual formulation of Sanofi's oral drug Riluzole. The bioequivalence study is meant to assess the pharmacokinetic equivalence of BHV-0223 with Rilutek (riluzole), for the treatment of Amyotrophic Lateral Sclerosis (ALS). Register today and get access to over 1000 Free Research Reports by joining our site below:


Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Biohaven Pharmaceutical Holding most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:


About BHV-0223

BHV-0223 is an innovative, sublingually, orally administered dissolving tablet (ODT), which uses the unique Zydis® ODT fast-dissolve technology. Biohaven is developing BHV-0223 as a potential treatment for patients with ALS. The tablet is being developed under an exclusive worldwide agreement with Catalent Inc., a global provider of drug delivery technology and development solutions for drugs, biologics, and consumer health products.

On February 25, 2016, Biohaven received a regulatory feedback from the US Food and Drug Administration (FDA), that the Section 505(b)(2) pathway was acceptable for BHV-0223 in ALS, and that there was no need of any additional efficacy or toxicology study for the submission of a new drug application (NDA) for this indication. This, coupled with the positive results of the bioequivalence study, would enable Biohaven to proceed towards completing an NDA and submitting it in the first half of 2018.

Study Objective and Results

The Bioequivalence Study has been specifically designed to establish the pharmacokinetic equivalence of sublingual BHV-0223, in comparison to the reference-listed drug Rilutek (riluzole), which is currently the standard of care treatment for patients suffering with ALS. For this study, a total of 138 healthy volunteers were administered BHV-0223 and Rilutek under fasted conditions.

The top-line results from the study show that 40mg dosage of sublingual BHV-0223 achieves results equivalent to 50mg dosage of Rilutek. In the pre-specified primary analysis, BHV-0223 achieved area-under-the-curve and peak exposures of about 90% and 113%, respectively, compared to those generated by generic Rilutek. The 90% confidence intervals were within the 80% to 125% range, which is used to define bioequivalence.

BHV-0223 Comparison with Rilutek

Although the FDA has approved Rilutek for the treatment of ALS, it gets difficult to administer conventional tablets to ALS patients as they have dysphagia or trouble in swallowing. On the other hand, when BHV-0223 is kept under the tongue, it dissolves in seconds and does not even require swallowing.

Also, Rilutek is often associated with dose-dependent effects on liver tests (transaminases), while BHV-0223 provides bioequivalent exposures with a 20% lower dose. This means, sublingual administration of 40mg BHV-0223 results in bioequivalent blood exposures to orally ingested 50mg tablets of Rilutek. Thus, due to this reduced drug exposure to the liver, BHV-0223 has a lower risk for causing liver test elevations.

An Important Development for ALS Patients

Positive results from the Bioequivalence Study are an important advancement for patients with ALS, especially for those can continue taking Rilutek despite difficulties in swallowing. Besides, the possibility of achieving an equivalent therapeutic exposure with a lower drug dose makes BHV-0223 more amenable to those patients who have concerns about liver toxicity.

Other Significant Developments for Biohaven

Apart from the current development in BHV-0223, Biohaven is also making significant progress in its oral, small molecule calcitonin gene receptor peptide (CGRP) antagonist for the treatment of migraine and glutamate modulation technology platforms for neurodegenerative diseases with high unmet need.

Stock Performance Snapshot

January 10, 2018 - At Wednesday's closing bell, Biohaven Pharmaceutical Holding's stock dropped 9.91%, ending the trading session at $27.09.

Volume traded for the day: 474.40 thousand shares, which was above the 3-month average volume of 305.94 thousand shares.

Stock performance in the last month – up 28.94%; previous six-month period – up 10.12%; and year-to-date - up 0.41%

After yesterday's close, Biohaven Pharmaceutical Holding's market cap was at $939.48 million.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry.


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SOURCE: Active-Investors