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Proven power for moderate to severe migraine*

ELYXYB consistently delivered significant pain relief and pain freedom vs placebo, with 1 in 3 patients reaching complete freedom from pain at 2 hours.5,8,9 See the Phase III Clinical Trial Program design.

*Patient-reported pre-dose pain intensity was mostly moderate (68.1%) and severe (31.5%).9
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Proven freedom from pain and most bothersome baseline symptoms

CO-PRIMARY ENDPOINTS

Pain freedom at 2 hours5

Study 1*

Bar chart showing 32% vs 25% pain freedom in Study 1 for ELYXYB and placebo, respectively*P value not significant.
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In study 1, ELYXYB delivered pain freedom at 2 hours in 32% of patients compared with 25% of patients taking placebo (P=0.076*)

Study 2

Bar chart showing 35% vs 21% pain freedom in Study 2 for ELYXYB and placebo, respectively
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In study 2, ELYXYB delivered pain freedom at 2 hours in 35% of patients compared with 21% of patients taking placebo (P<0.001).

Freedom from most bothersome symptom (MBS) at 2 hours5

Study 1

Chart showing 58% and 44% freedom from most bothersome symptom in Study 1 for ELYXYB and placebo, respectively
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In study 1, ELYXYB delivered freedom from baseline MBS at 2 hours in 58% of patients compared with 44% of patients on placebo (P=0.003).

Study 2

Chart showing 57% and 44% freedom from most bothersome symptom in Study 2 for ELYXYB and placebo, respectively
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In study 2, ELYXYB delivered freedom from baseline MBS at 2 hours in 57% of patients compared with 44% of patients on placebo (P<0.006).

Hear from an expert

Dr. Richard Lipton

Watch as Dr. Richard Lipton, Director of the Montefiore Headache Center, discusses ELYXYB’s clinical data.

See Clinical Data Video
Dr. Jessica Ailani

Hear from Georgetown Headache Center’s Dr. Jessica Ailani about how unique features of ELYXYB can address patients’ needs.

See ELYXYB's role in migraine

Proven pain relief that lasts

SECONDARY ENDPOINTS

Pain relief at 1, 1.5, and 2 hours8,9

Legend for the graph: ELYXYB is a pink and purple gradient, Placebo is grey.

Study 1

 Bar chart showing rates of pain relief with ELYXYB and placebo at 1, 1.5, and 2 hours in Study 1
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Study 1: Percent of patients who experienced pain relief on ELYXYB vs placebo, respectively8:

  • 60 min: 49% vs 39% (P=0.021)
  • 90 min: 59% vs 48% (P=0.014)
  • 120 min: 68% vs 55% (P=0.004)
  • Study 2

    Bar chart showing rates of pain relief with ELYXYB and placebo at 1, 1.5, and 2 hours in Study 2
    Image Description +

    Study 2: Percent of patients who experienced pain relief on ELYXYB vs placebo, respectively9:

  • 60 min: 57% vs 45% (P=0.009)
  • 90 min: 70% vs 55% (P<0.001)
  • 120 min: 75% vs 61% (P<0.001)
  • Significant patient satisfaction with sustained pain relief and lower use of rescue medication

    Upward arrow icon with overlaid checkmark icon
    • 55% of patients taking ELYXYB experienced pain relief at 2 hours, sustained through 24 hours9
    • 84% of patients did not take rescue medication with ELYXYB9
    • Significant patient satisfaction scores vs placebo at 2 and 24 hours9
    • Significant improvement in functional disability score by 2 hours9
    Sustained pain relief from 2 to 24 hours post-dose was defined as pain relief at 2 hours post-dose, with no use of rescue medication and no worsening of headache pain within 2 to 24 hours post-dose.9

    Freedom from photophobia, phonophobia, and nausea

    Photophobia freedom

    Photophobia freedom

    Study 1

    57%

    vs 41% on placebo8(P<0.001)
    Study 2

    58%

    vs 44% on placebo9(P<0.002)
    Phonophobia freedom

    Phonophobia freedom

    Study 1

    58%

    vs 46% on placebo8(P<0.019)
    Study 2

    61%

    vs 55% on placebo9(P<0.186)
    Nausea freedom

    Nausea freedom

    Study 1

    67%

    vs 59% on placebo8,10(P=0.046)
    Study 2

    68%

    vs 62% on placebo9(P<0.394)
    Image Description +

    In study 1, the proportion of patients (vs placebo) who reached freedom from photophobia, phonophobia, and nausea at 2 hours was8,10:

    • Photophobia freedom: 57% (vs 41%; P<0.001)
    • Phonophobia freedom: 58% (vs 46%; P<0.019)
    • Nausea freedom: 67% (vs 59%: P=0.046)

    In study 2, the proportion of patients (vs placebo) who reached freedom from photophobia, phonophobia, and nausea at 2 hours was9:

    • Photophobia freedom: 58% (vs 44%; P<0.002)
    • Phonophobia freedom: 61% (vs 55%; P<0.186)
    • Nausea freedom: 68% (vs 62%; P<0.394)

    Proven timeline for migraine treatment: Faster results within 1 hour when patients chose timing of the dose4

    Phase III, study 2 of ELYXYB was designed with 2 treatment periods. In treatment period 1, patients were instructed to wait for moderate to severe pain levels before dosing. In treatment period 2, patients were re-randomized and allowed to time the dose at their discretion.

    Timeline arrow with 30 min phono and photophobia, 45 min pain relief, and 60 min pain freedom
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    Significant improvement vs placebo was demonstrated as early as:

    • 30 minutes: Photophobia (P=0.052), Phonophobia (P=0.014)
    • 45 minutes: Pain relief (P=0.021)
    • 60 minutes: Pain freedom (P=0.049)
    Check mark icon

    Pain freedom
    at 2 hours 46%

    (P<0.001)
    Check mark icon

    MBS freedom
    at 2 hours 63%

    (P=0.010)
    Check mark icon

    Sustained 2- to 24-hour
    pain relief 63%

    (P=0.023)
    Check mark icon

    Functional disability score vs placebo improved by 50%

    (P<0.001)

    Well-tolerated. Low incidence of AEs.

    The safety and tolerability of ELYXYB were established in 2 Phase III trials of 1253 patients.8,9

    No serious treatment-emergent adverse events (TEAEs), deaths, or drug-related TEAEs leading to treatment withdrawal occurred in studies of ELYXYB.8,9

    No clinically meaningful changes from baseline in clinical laboratory variables, vital statistics, or ECG readings.8,9

    No drowsiness associated with ELYXYB in clinical trials, and incidence of dizziness and nausea was comparable to placebo.5,10

    Most common adverse reaction (≥2% of patients who received ELYXYB and greater than placebo) was dysgeusia (3% of patients on ELYXYB vs 1% on placebo).5

    Study design

    ELYXYB Phase III Clinical Trial Program: 1253 patients were enrolled across 2 Phase III trials. Study 1 included 631 patients and study 2 included 622 patients. The co-primary endpoints were 2-hour pain freedom and 2-hour freedom from MBS.5,8,9

    Study design for treatment periods 1 and 2.
    Image Description +

    After screening, patients were randomized 1:1 to receive either ELYXYB or placebo. In Treatment Period 1, patients waited until moderate to severe levels before taking the dose. Patients were then re-randomized 1:1 for Treatment Period 2 and were permitted to time the dose at their own discretion.

    View dosing and prescribing information

    Go to Prescribing ELYXYB

    INDICATION

    ELYXYB (celecoxib) oral solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine with or without aura in adults.

    Limitations of Use

    ELYXYB is not indicated for the preventive treatment of migraine.

    IMPORTANT SAFETY INFORMATION about ELYXYB

    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.
    • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    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.

    INDICATION

    ELYXYB (celecoxib) oral solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine with or without aura in adults.

    Limitations of Use

    ELYXYB is not indicated for the preventive treatment of migraine.

    CONTRAINDICATIONS

    ELYXYB is contraindicated in the following patients:

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

    WARNINGS AND PRECAUTIONS

    Post-MI Patients: Avoid the use of ELYXYB in patients with a recent 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.

    Hepatotoxicity: Elevations of ALT or AST have been reported in patients with NSAIDs. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure, have been reported. Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop.

    IMPORTANT SAFETY INFORMATION about ELYXYB

    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.
    • ELYXYB is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

    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.

    Hypertension: NSAIDs, including ELYXYB, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking some antihypertension medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.

    Heart Failure and Edema: 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.

    Renal Toxicity: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury and may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ELYXYB in patients with severe renal impairment unless benefits are expected to outweigh the risk of worsening renal function. If ELYXYB is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

    Hyperkalemia: Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

    Anaphylactic Reactions: Celecoxib has been associated with anaphylactic reactions in patients with and without known hypersensitivity to celecoxib and in patients with aspirin-sensitive asthma. Celecoxib is a sulfonamide and both NSAIDs and sulfonamides may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.

    Exacerbation of Asthma Related to Aspirin Sensitivity: ELYXYB is contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without known aspirin sensitivity).

    Serious Skin Reactions: Serious skin reactions have occurred following treatment with celecoxib, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). These serious events may occur without warning and can be fatal. Discontinue ELYXYB at the first appearance of skin rash or any other sign of hypersensitivity.

    Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): DRESS has been reported in patients taking NSAIDs. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Eosinophilia is often present. If such signs or symptoms are present, discontinue ELYXYB and evaluate the patient immediately.

    Medication Overuse Headache: Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, NSAIDs, or combination of these drugs for 10 or more days per month), including ELYXYB, may lead to exacerbation of headache (medication overuse headache). Detoxification of patients, including withdrawal of the overused drugs and treatment of withdrawal symptoms may be necessary.

    Premature Closure of Fetal Ductus Arteriosus: ELYXYB may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including ELYXYB, in pregnant women starting at about 30 weeks gestation and later.

    Oligohydramnios/Neonatal Renal Impairment: Use of NSAIDs, including ELYXYB, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit ELYXYB use to the lowest effective dose and shortest duration possible. Discontinue ELYXYB if oligohydramnios occurs.

    Hematological Toxicity: Anemia has occurred in NSAID-treated patients. Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia or blood loss. NSAIDs, including ELYXYB, may increase the risk of bleeding events. Monitor patients for signs of bleeding.

    Masking of Inflammation and Fever: The pharmacological activity of celecoxib in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

    Laboratory Monitoring: Because serious GI bleeding, hepatotoxicity, and renal injury can occur without warning symptoms or signs, consider monitoring patients on long-term NSAID, including ELYXYB, treatment with a CBC and a chemistry profile periodically.

    Disseminated Intravascular Coagulation (DIC): ELYXYB is not indicated in pediatric patients or for the treatment of juvenile rheumatoid arthritis (JRA). Disseminated intravascular coagulation has occurred with use of celecoxib capsules in pediatric patients with systemic-onset JRA, which required monitoring for signs and symptoms of abnormal clotting or bleeding.

    DRUG INTERACTIONS

    Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking ELYXYB with drugs that interfere with hemostasis. Concomitant use of ELYXYB and oral corticosteroids, antiplatelet drugs (e.g., aspirin), anticoagulants, or selective serotonin reuptake inhibitors (SSRIs), is not recommended.

    ACE Inhibitors, Angiotensin Receptor Blockers (ARB), or Beta-Blockers: Concomitant use with ELYXYB may diminish the antihypertensive effect of these drugs. Monitor blood pressure.

    ACE Inhibitors and ARBs: Concomitant use with ELYXYB in the elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.

    Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.

    Digoxin: Concomitant use with ELYXYB can increase serum concentration and prolong half-life of digoxin. Monitor serum digoxin levels.

    USE IN SPECIFIC POPULATIONS

    Pregnancy: Use of NSAIDs during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks gestation.

    Infertility: NSAIDs are associated with reversible infertility. Consider withdrawal of ELYXYB in women who have difficulties conceiving.

    ADVERSE REACTIONS

    Most common adverse reaction (at least 3% and greater than placebo) reported by patients treated with ELYXYB in the clinical trials was dysgeusia.

    Please see full Prescribing Information, including Boxed Warning and Medication Guide for ELYXYB.

    To report SUSPECTED ADVERSE REACTIONS, contact BioDelivery Sciences International, Inc. at 1-800-469-0261 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

    Intended for healthcare professionals of the United States of America only.

    AE=adverse event; COX=cyclooxygenase; GI=gastrointestinal; NSAID=nonsteroidal anti-inflammatory drug.