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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Hikma Pharmaceuticals Plc | LSE:HIK | London | Ordinary Share | GB00B0LCW083 | ORD SHS 10P |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
59.00 | 3.18% | 1,913.00 | 1,916.00 | 1,918.00 | 1,920.00 | 1,861.00 | 1,861.00 | 522,491 | 16:35:11 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
Pharmaceutical Preparations | 2.88B | 192M | 0.8685 | 22.08 | 4.24B |
PR Newswire
LONDON, Feb. 5, 2024
Offers health care providers a new multimodal approach to adult pain management
LONDON, Feb. 5, 2024 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the launch of COMBOGESIC® IV (acetaminophen and ibuprofen) injection in the US.
COMBOGESIC® IV is an intravenous, opioid-free pain relief medicine that is a combination of 1,000 mg of acetaminophen and 300 mg of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). It was approved by the US FDA in October 2023 for use in adults where an intravenous route of administration is considered clinically necessary for: (i) the relief of mild to moderate pain; and (ii) the management of moderate to severe pain as an adjunct to opioid analgesics.1
The American Society of Anesthesiology's (ASA) evidence-based recommendations emphasize the importance of a multimodal approach to pain management using multiple interventions with different mechanisms of action that may offer additive or synergistic effects to optimize pain relief.2
COMBOGESIC® IV offers health care providers a new, non-opioid approach to pain management by combining active drug substances with different mechanisms of action in a single formulation, providing:
In a Phase 3 clinical trial, COMBOGESIC® IV provided more than double the pain relief than that of acetaminophen IV and ibuprofen IV alone.3 Time to meaningful pain relief was shorter in the COMBOGESIC® IV group than that in the Ibuprofen IV or placebo groups.3 COMBOGESIC® IV also allows for superior analgesia efficacy.3
"The approval of COMBOGESIC® IV is an important step in providing hospitals and health care providers in the US with an alternative treatment option for managing patients' pain," said Dr. Bill Larkins, President of Injectables, Hikma. "This is another example of how we continue to expand our portfolio of critical medicines and we are pleased to make this important new treatment option available for patients, helping to put better health within reach, every day."
In 2021, Hikma signed an exclusive license and distribution agreement with AFT Pharmaceuticals (AFT) for the commercialization of COMBOGESIC® IV in the US. Under the trade name of MAXIGESIC® IV outside of the United States, COMBOGESIC® IV is licensed in over 100 countries and marketed in over 20 countries.
About COMBOGESIC® IV
COMBOGESIC® IV is the only IV analgesic therapy formulated with 1,000 mg of acetaminophen and 300 mg of ibuprofen, utilizing the synergistic effect of both medicines for optimal pain relief.1 It offers health care providers a new approach to multimodal analgesia by combining active drug substances with different mechanisms of action that harness additive or synergistic effects to provide more effective pain relief compared with individual components used as single-modality interventions.1-3 COMBOGESIC® IV is supplied as a readily available solution with no mixing required for administration.1 It is administered as a 15-minute IV infusion, every 6 hours as needed, not to exceed the maximum total daily dose of 4,000 mg acetaminophen and 1,200 mg of ibuprofen in 24 hours.1
Enquiries | |
Hikma Pharmaceuticals PLC | |
Susan Ringdal | +44 (0)20 7399 2760/ +44 7776 477050 |
EVP, Strategic Planning and Global Affairs | uk-investors@hikma.uk.com |
Steve Weiss | +1 732 788 8279 |
David Belian | +1 848 254 4875 |
US Communications and Public Affairs | uscommunications@hikma.com |
About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/positive Fitch)
Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we've been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the North America, the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people's lives. We're committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,800 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com
This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.
IMPORTANT SAFETY INFORMATION
WARNING: HEPATOTOXICITY, CARDIOVASCULAR RISK, and GASTROINTESTINAL RISK | |
• | RISK OF MEDICATION ERRORS: Take care when prescribing, preparing, and administering COMBOGESIC® IV to avoid dosing errors which could result in accidental overdose and death. |
• | HEPATOTOXICITY: COMBOGESIC® IV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with doses of acetaminophen that exceed 4,000 mg per day, and often involve more than one acetaminophen-containing product. |
• | CARDIOVASCULAR RISK: COMBOGESIC® IV contains ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID). 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 treatment and may increase with duration of use. |
• | COMBOGESIC® IV is contraindicated for treatment of peri-operative 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. |
CONTRAINDICATIONS
COMBOGESIC® IV is contraindicated in:
WARNINGS & PRECAUTIONS
ADVERSE REACTIONS
The most common TEAEs (occurring in ≥ 3% of COMBOGESIC® IV -treated participants) were related to the infusion site (infusion site pain, infusion site extravasation), or affected the gastrointestinal (nausea, vomiting, constipation) or nervous (dizziness, headache, somnolence) systems. Other skin and subcutaneous-related TEAEs (pruritis, hyperhidrosis) also affected around 2 to 3% of the study population, as did procedural nausea and polyuria.
DRUG INTERACTIONS
A number of known or potential interactions between COMBOGESIC® IV and other drugs/drug classes exist. Please refer to the Drug Interactions in the Prescribing Information for further information.
USE IN SPECIFIC POPULATIONS
INDICATIONS AND USAGE
COMBOGESIC® IV is indicated in adults (over age 18) where an intravenous route of administration is considered clinically necessary for:
LIMITATIONS OF USE
COMBOGESIC® IV is indicated for short-term use of five days or less.
Patient counseling information should be shared with the patient prior to administration. For additional information, please refer to the Package Insert for full Prescribing Information, available on www.hikma.com.
To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured by:
S.M. Farmaceutici SRL
Zona Industriale, 85050 Tito (PZ), Italy
Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922 USA
COMBOGESIC® is a registered trademark of AFT Pharmaceuticals Limited.
© 2024 Hikma Pharmaceuticals USA Inc. All rights reserved.
Document identification number: HK-2471-v3
1 COMBOGESIC® IV (acetaminophen 1000 mg and ibuprofen 300 mg) [package insert].
2 Chou R, Gordon DB, de Leon-Casasola OA, et al. Management of post operative pain: a clinical practice guideline from the American pain society, the American society of regional anesthesia and pain medicine, and the American society of anesthesiologists' committee on regional anesthesia, executive committee, and administrative council. J Pain. 2016;17:131-157.
3 Daniels SE, Playne R, Stanescu I, Zhang J, Gottlieb IJ, Atkinson HC. Efficacy and safety of an intravenous acetaminophen/ibuprofen fixed-dose combination after bunionectomy: A randomized, double-blind, factorial, placebo-controlled trial. Clinical Therapeutics. 2019;41(10).
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SOURCE Hikma Pharmaceuticals USA Inc.
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