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Iroko Pharmaceuticals Announces New Results From Solumatrix® NSAID Portfolio In Acute Pain And Osteoarthritis


5/1/2014 11:12:53 AM

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PHILADELPHIA, May 1, 2014 — Iroko Pharmaceuticals, LLC, a Philadelphia-based pharmaceutical company dedicated to advancing the science of analgesia, today announced the presentation of new data from two Phase 3 studies of its SoluMatrix® nonsteroidal anti-inflammatory drug (NSAID) portfolio. Data presented include results from a study of post-surgical acute pain showing that fewer patients taking TIVORBEX™ (indomethacin) capsules needed additional opioid-containing analgesia compared to placebo over a 48 hour period following surgery1. Additionally, data from a different study showed that treatment with ZORVOLEX® (diclofenac) capsules resulted in improvement in patient reported outcomes and quality of life measures in individuals with osteoarthritis (OA) of the hip and knee when compared to placebo2.

“As a leader in the pain management space, we are continuing to study the SoluMatrix® NSAIDs in our portfolio to understand how they can better address unmet needs in analgesia,” said John Vavricka, President and CEO of Iroko Pharmaceuticals. “We are encouraged by this new data that demonstrate the real-world application of our low dose NSAIDs in limiting the use of opioids and improving patient-associated measures of pain1,2, two important areas in pain management. These data further establish ZORVOLEX and TIVORBEX as promising therapeutic options.”

ZORVOLEX and TIVORBEX are part of Iroko’s low dose NSAID portfolio created using proprietary SoluMatrix Fine Particle Technology™, which produces NSAIDs as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. Both ZORVOLEX and TIVORBEX were recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate acute pain in adults3,4. A supplemental New Drug Application (sNDA) for ZORVOLEX for the treatment of osteoarthritis (OA) pain was also accepted for review by FDA in January 2014.

About the Phase 3 Data Evaluating TIVORBEX in Patients with Post-Surgical Acute Pain

Results from a pivotal Phase 3 study of TIVORBEX in acute pain will be presented at the American Pain Society’s (APS) 33rd Annual Scientific Meeting, taking place April 30 – May 3 in Tampa, FL. The analysis assessed opioid rescue medication usage in 462 patients, aged 18–68 years, experiencing significant post-surgical pain, who were randomized to receive TIVORBEX 40 mg three times daily (TID) or twice daily (BID) or 20 mg TID, celecoxib (400 mg loading dose followed by 200 mg BID), or placebo1.

As expected for patients with post-surgical pain of this magnitude, a high proportion of patients in all study arms required additional rescue analgesia, hydrocodone/acetaminophen or oxycodone/acetaminophen, over the 48 hours following randomization.

“Whenever possible, it is important for healthcare providers to avoid prescribing treatments that can be associated with the potential for dependency and diversion,” said Dr. Clarence Young, Chief Medical Officer of Iroko Pharmaceuticals. “Patients treated with TIVORBEX in this study required less opioid rescue medication compared to placebo, suggesting that TIVORBEX is a valuable treatment option for patients with acute pain.”

Results showed the following1:

• About half as many opioid-containing rescue medication tablets were used in the TIVORBEX arms compared to the placebo group over 48 hours. Patients randomized to the 40 mg of TIVORBEX three times daily and twice daily treatment arms used an average of 2.7 tablets of opioid containing analgesics, also referred to as rescue medication; the TIVORBEX 20 mg three times daily group used an average of 3.0 tablets, the celecoxib group used an average of 3.1 tablets, and patients in the placebo group used an average of 5 tablets.

• The time to first use of rescue medication, measured following the start of treatment with either TIVORBEX or placebo, occurred later on average in the TIVORBEX 40 mg three times daily, 40 mg twice daily and celecoxib 200 mg twice daily groups compared with placebo. The difference was statistically significant for the TIVORBEX 40 mg three times daily group (P = 0.008) compared to placebo.

• The most common adverse events in this study (>5%) included nausea, dizziness, and vomiting, and were generally similar across treatment groups.

About the Phase 3 Data Evaluating ZORVOLEX in Patients with Osteoarthritis

An analysis of the pivotal Phase 3 ZORVOLEX trial, presented at the 2014 Osteoarthritis Research Society International (OARSI) World Congress, which took place April 24 – April 27 in Paris, France, assessed a number of patient reported outcomes and quality of life measures including: Patient Global Impression of Change (PGIC) and Medical Outcomes Survey Short Form 36 (SF-36), version 2. The SF-36 is comprised of 36 survey questions assessing different domains of function including: physical functioning, role physical, bodily pain, vitality and social functioning2.

Following 12 weeks of treatment2:

• The overall differences in PGIC compared with placebo were significant in the ZORVOLEX 35 mg three times daily (P < 0.0001) and twice daily (P = 0.0008) treatment groups. Two-thirds of patients receiving ZORVOLEX 35 mg three times daily (P < 0.0006) and half of the patients receiving ZORVOLEX 35 mg twice daily (P = 0.0071) reported PGIC as “very much” or “much” improved relative to placebo.

• Patients treated with ZORVOLEX 35 mg three times daily reported statistically significant improvements in 5 SF-36 domains, 4 of which were clinically meaningful (=Minimally Clinical Important Difference). These included physical functioning, role physical, bodily pain and social functioning.

• The most common adverse events (>2%) in studies of ZORVOLEX include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, flatulence, pain in extremity and dyspepsia.

“Up to 50 percent of all NSAID prescriptions are written for osteoarthritis5, a condition that significantly contributes to disability, especially among older adults,” said Dr. Martin J. Bergman, Clinical Assistant Professor of Medicine at Drexel University College of Medicine, and a study author. “However, NSAIDs, like all pain treatments, have associated risks, particularly at higher doses6,7. That’s why it’s important to use the lowest effective dose of these agents, particularly in patients with osteoarthritis, who may require long-term treatment.”

About ZORVOLEX

ZORVOLEX is the first low dose FDA-approved NSAID developed using proprietary SoluMatrix Fine Particle Technology™ that is now available by prescription. ZORVOLEX contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. ZORVOLEX was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals. ZORVOLEX is not approved for the treatment of osteoarthritis pain. A supplemental New Drug Application seeking approval for this indication is currently being reviewed by FDA. For more information, visit www.ZORVOLEX.com.

About TIVORBEX

TIVORBEX is an FDA-approved NSAID developed using proprietary SoluMatrix Fine Particle Technology™. TIVORBEX contains indomethacin as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. TIVORBEX is part of Iroko’s low dose NSAID pipeline, and was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration of time consistent with individual patient treatment goals.

Important Safety Information about ZORVOLEX

ZORVOLEX is indicated for the treatment of mild to moderate acute pain in adults.

Cardiovascular Risk

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

ZORVOLEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk

NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events.

ZORVOLEX is contraindicated in patients with: a known hypersensitivity to diclofenac or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

ZORVOLEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Elevation of one or more liver tests may occur during therapy with ZORVOLEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with ZORVOLEX. ZORVOLEX should be discontinued immediately if abnormal liver tests persist or worsen.

NSAIDS, including ZORVOLEX, can lead to the new onset or worsening of existing hypertension which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with ZORVOLEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists.

Fluid retention and edema have been observed in some patients taking NSAIDs. ZORVOLEX should be used with caution in patients with fluid retention or heart failure.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. ZORVOLEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors.

Treatment with ZORVOLEX in patients with advanced renal disease is not recommended.

Anaphylactoid reactions may occur in patients with the aspirin triad or in patients without prior exposure to ZORVOLEX and should be discontinued immediately if an anaphylactoid reaction occurs.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens – Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. ZORVOLEX should be discontinued if rash or other signs of local skin reaction occur.

Starting at 30 weeks gestation, ZORVOLEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.

Concomitant administration of diclofenac and aspirin or anticoagulants is not generally recommended because of the risk of increased GI bleeding higher than users of either drug alone.

Most common adverse reactions in clinical trials (incidence =2%) include: edema, nausea, headache, dizziness, vomiting, constipation, pruritus, flatulence, pain in extremity, and dyspepsia.

ZORVOLEX capsules do not result in an equivalent systemic exposure to diclofenac as other oral formulations. Therefore, do not substitute similar dosing strengths of other diclofenac products for ZORVOLEX.

Please see full Prescribing Information for additional important safety and dosing information.

For more information, visit www.ZORVOLEX.com.
Important Safety Information about TIVORBEX

Cardiovascular Risk

Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.

TIVORBEX is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal 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 are at greater risk for serious gastrointestinal events.

TIVORBEX is contraindicated in patients with: a known hypersensitivity to indomethacin or its inactive ingredients; a history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.

TIVORBEX should be used at the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Elevation of one or more liver tests may occur during therapy with NSAIDs, including TIVORBEX. Physicians should measure transaminases (ALT and AST) periodically in patients receiving long-term therapy with TIVORBEX. TIVORBEX should be discontinued immediately if abnormal liver tests persist or worsen.

NSAIDs, including TIVORBEX, can lead to the new onset or worsening of existing hypertension, which may contribute to the increased incidence of cardiovascular events. Blood pressure should be monitored closely during treatment with TIVORBEX. NSAIDs may diminish the antihypertensive activity of thiazides, loop diuretics, ACE inhibitors and angiotensin II antagonists.

Fluid retention and edema have been observed in some patients taking NSAIDs. TIVORBEX should be used with caution in patients with fluid retention or heart failure.

Long-term administration of NSAIDs can result in renal papillary necrosis and other renal injury. TIVORBEX should be used with caution in patients at greatest risk of this reaction, including the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics and ACE inhibitors. Treatment with TIVORBEX in patients with advanced renal disease is not recommended.

Anaphylactic reactions may occur in patients with the aspirin triad or in patients without prior exposure to TIVORBEX and should be discontinued immediately if an anaphylactic reaction occurs.

Indomethacin may aggravate depression, and other psychiatric disturbances, epilepsy, or parkinsonism, and should be used with caution in patients with these conditions. Indomethacin may cause drowsiness; therefore patients should be cautioned about engaging in activities requiring mental alertness and motor coordination. Discontinue TIVORBEX if severe central nervous system (CNS) adverse reactions develop.

NSAIDs can cause serious skin adverse events such as exfoliative dermatitis, Stevens - Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. TIVORBEX should be discontinued if rash or other signs of local skin reaction occur.

Starting at 30 weeks’ gestation, TIVORBEX and other NSAIDs should be avoided by pregnant women as premature closure of the ductus arteriosus in the fetus may occur.

Concomitant administration of indomethacin and aspirin or anticoagulants is not generally recommended because the risk of increased GI bleeding is higher than in users of either drug alone.

Most common adverse reactions in clinical trials (incidence =2%) include: nausea, post procedural edema, headache, dizziness, vomiting, post procedural hemorrhage, constipation, pruritus, diarrhea, dyspepsia, post procedural swelling, presyncope, rash, upper abdominal pain, somnolence, generalized pruritus, hyperhidrosis, decreased appetite, hot flush, and syncope.

Please see full Prescribing Information for additional important safety and dosing information.

About Iroko Pharmaceuticals, LLC
Iroko is a global specialty pharmaceutical company, based in Philadelphia, dedicated to advancing the science of analgesia. The company develops and globally commercializes pharmaceutical products. In addition to the Iroko products that are marketed worldwide, the company has a robust pipeline of investigational low dose NSAID products being developed using iCeutica Inc.’s proprietary SoluMatrix Fine Particle Technology™. For more information, visit www.iroko.com.

Contacts:
Jessica Donnelly for Iroko Pharmaceuticals, LLC, 212-798-9819
Kate de Santis, Iroko Pharmaceuticals, LLC, 267-546-1682

SoluMatrix Fine Particle Technology™ is a trademark of iCeutica Inc., and is licensed to Iroko for exclusive use in NSAIDs. SoluMatrix® is a trademark of iCeutica Pty Ltd, and is licensed to Iroko for exclusive use in NSAIDs. ZORVOLEX and TIVORBEX are trademarks of Iroko Properties, Inc.

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