BioDelivery Sciences International Announces ELYXYB™ is Now Available in the U.S. for the Acute Treatment of Migraine

The First and Only FDA-Approved, Ready-to-Use Oral Solution for the Acute Treatment of Migraine with or without Aura in Adults

Expands BDSI Portfolio and Establishes Growth Platform in Neurology

RALEIGH, N.C., Feb. 24, 2022 (GLOBE NEWSWIRE) — BioDelivery Sciences International, Inc. (NASDAQ: BDSI), a growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions, today announced the U.S. commercial launch and availability of ELYXYBTM (celecoxib oral solution), the first and only FDA-approved ready-to-use oral solution for the acute treatment of migraine with or without aura in adults.

“ELYXYB represents a significant innovation in the rapidly growing migraine market and our initial entry into the Neurology space, which is complementary to our current sales and marketing efforts,” stated Jeff Bailey, CEO of BDSI. “We have been diligently preparing for this launch and are ready and excited to deliver this important acute treatment option to patients who are experiencing the life-altering effects of migraine disease.”

Migraine is a debilitating condition for almost 40 million people in the U.S. Many patients with migraine are searching for acute treatments that provide relief quickly and conveniently, without interfering with daily quality of life.

“Millions of patients are cycling through the multitude of current migraine treatments, searching for what will work quickly and what will last, whenever a migraine strikes,” stated Peter McAllister, MD, Director of the New England Center for Neurology and Headache. “Physicians are looking for new treatment options that are effective, with favorable safety and tolerability, and less contraindications. ELYXYB is uniquely formulated to provide fast-acting, long-lasting relief in a convenient, ready-to-use oral solution, and will be a go-to option for many of my patients with migraine.”

ELYXYB is an oral solution of celecoxib, formulated using a self-microemulsifying drug delivery system (SMEDDS) that improves solubility and bioavailability leading to better absorption1. This allows for the administration of a lower dose of drug to achieve therapeutic effect relative to a higher dose of the conventional oral capsule, which doesn’t have the rapid onset of action that migraine patients need. ELYXYB comes in a small, single-dose bottle that does not require premixing, shaking, or measuring, making it convenient for patients to take immediately upon the onset of a migraine attack.

BDSI is committed to ensuring access to appropriate patients who are prescribed ELYXYB. The ELYXYB Passport Program provides access support and resources to both healthcare providers and patients, including a co-pay savings program.

For more information on ELYXYB and the ELYXYB Passport Program visit ELYXYB.com.

ELYXYB is protected by six Orange Book-listed method-of-use patents that expire in 2036 as well as by New Product Exclusivity expiring in May 2023.

Please see Important Safety Information about ELYXYB below.

ABOUT BIODELIVERY SCIENCES INTERNATIONAL, INC.

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) is a commercial-stage specialty pharmaceutical company dedicated to patients living with chronic conditions. BDSI has built a portfolio of differentiated products that address serious and debilitating conditions, including chronic pain, migraine, and opioid-induced constipation.

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, expectations regarding the commercial launch of ELYXYB and BDSI’s expansion in to the neurology space, 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 the risk that the current COVID-19 pandemic impacts on our supply chain, commercial partners, patients and their physicians and the healthcare facilities in which they work, and our personnel are greater than we anticipate, as well as 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.

ELYXYB INDICATION AND USAGE

ELYXYB is indicated in adults for the acute treatment of migraine with or without aura.

Limitations of Use: ELYXYB is not indicated for the preventive treatment of migraine.

ELYXYB IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
  • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) and Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events [see Warnings and Precautions (5.2)].

ELYXB is contraindicated in patients with:

  • Known hypersensitivity to celecoxib, any components of the drug product, or sulfonamides (4)
  • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4)
  • In the setting of CABG surgery (4)

To minimize the potential risk for an adverse cardiovascular (CV) event in NSAID-treated patients, use ELYXYB for the fewest number of days per month as needed, based on individual treatment goals. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

Avoid the use of ELYXYB in patients with a recent myocardial infarction (MI) unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ELYXYB is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

NSAIDs, including ELYXYB, can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with celecoxib. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term NSAID therapy is not without risk.

Avoid the use of ELYXYB in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If ELYXYB is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs, including ELYXYB.

Long-term administration of NSAIDs, including celecoxib, the active ingredient in ELYXYB, has resulted in renal papillary necrosis and other renal injury.

No information is available from controlled clinical studies regarding the use of celecoxib in patients with severe renal impairment. The renal effects of celecoxib may hasten the progression of renal dysfunction in patients with preexisting renal disease.

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, nonsteroidal anti-inflammatory drugs or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.

NSAIDs, including ELYXYB, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders or concomitant use of warfarin, other anticoagulants, antiplatelet drugs (e.g., aspirin), SSRIs, and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

Most common adverse reaction (at least 3% and greater than placebo) is dysgeusia.

These are not all the side effects associated with ELYXYB.

Please see Patient Information, Instructions For Use, Medication Guide and Full Prescribing Information for ELYXYB

(https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212157s000lbl.pdf)

Arindam Pal, Srinivas Shenoy, Anirudh Gautam, Sagar Munjal, Jing Niu, Mathangi Gopalakrishnan & Joga Gobburru, Clinical Drug Investigation volume 37, pages 937–946(2017)

© 2022 BioDelivery Sciences International, Inc. All rights reserved.

Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
[email protected]

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