BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with chronic conditions, announced today that it has completed the acquisition of U.S. and Canadian rights to ELYXYB™ (celecoxib oral solution) from Dr. Reddy’s Laboratories Limited.
ELYXYB is the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults. BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine attacks.
Migraine is a debilitating condition for almost 40 million people in the U.S. Many acute migraine sufferers are searching for treatments that provide relief quickly and conveniently.
“The availability of ELYXYB represents a significant therapeutic development for the acute treatment of migraine,” stated Richard Lipton, MD, Edwin S. Lowe Chair in Neurology at Albert Einstein College of Medicine, Director of the Montefiore Headache Center, and one of the clinical investigators for the ELYXYB studies. “With the rapid onset of action delivered in a unique, ready-to-use oral solution, ELYXYB provides a convenient, quick-relief treatment option to help patients return to functioning in their everyday lives.”
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ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption1. This allows for the administration of a lower dose of the drug to achieve a therapeutic effect relative to a conventional oral solid dosage form. For adult patients who suffer from the debilitating and disruptive effects of migraines, there continues to be a need for reliable and efficacious treatment options. ELYXYB’s unit-dose oral solution makes it convenient for patients to take it immediately upon the emergence of acute migraine attacks.
“ELYXYB’s pivotal studies showed that the percentage of patients achieving Most Bothersome Symptom (MBS) freedom at two hours post-dose was significantly greater for those patients receiving ELYXYB versus those receiving placebo. Study 2 demonstrated that the percentage of patients reaching headache pain freedom two hours post-dose was significantly greater for those receiving ELYXYB versus those receiving placebo. The data also showed a meaningful speed of onset with Tmax achieved in approximately 60 minutes,” said Thomas Smith, MD, Chief Medical Officer at BDSI, and a former thought leader in the migraine space. “BDSI looks forward to expanding our impact in Migraine and to deepening our commitment to our patients-first philosophy.”
“The acquisition of ELYXYB represents a critical step to building our presence in Neurology which is an excellent strategic adjacency to our pain franchise,” said Jeff Bailey, CEO of BDSI.
“We are confident that ELYXYB will contribute to BDSI’s revenue growth and profitability over time, with patent protection until 2036. Our extensive commercial expertise, robust corporate infrastructure, and strong financial position will allow us to successfully commercialize ELYXYB and continue to pursue additional value-enhancing business development opportunities,” Bailey indicated.
BDSI will host an Investor Day on October 14, 2021, to discuss ELYXYB in further detail.
Please see Important Safety Information about ELYXYB below.
CAUTIONARY NOTE ON FORWARD-LOOKING STATEMENTS
This press release and any statements of employees, representatives, and partners of BioDelivery Sciences International, Inc. (“BDSI”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to BDSI’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of BDSI’s management and are subject to significant risks and uncertainties, including those detailed in BDSI’s filings with the Securities and Exchange Commission. Actual results (including, without limitation, the contribution of ELYXYB to the Company’s revenue growth and shareholder value, the timing of the commercial launch of ELYXYB, the Company’s expansion into neurology, the growth of the migraine market, and the significant unmet need in pediatric migraine patients may differ materially from those set forth or implied in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond BDSI’s control), including those set forth in our 2020 annual report on Form 10-K filed with the US Securities and Exchange Commission and subsequent filings. BDSI undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future presentations, or otherwise, except as required by applicable law.
Source: Biospace