Tapentadol Hydrochloride

AACHEN, Germany and YEOJU, South Korea, March 5, 2026 /PRNewswire/ -- Grünenthal, a global leader in pain management and related diseases, and BCWorld Pharm Co., Ltd. ("BCWP"), a specialty company actively expanding and diversifying its pain management portfolio through global open innovation partnerships, announced today that they have entered into a definitive agreement whereby BCWP will have the exclusive South Korean rights to Qutenza®, a topical, non-systemic, non-opioid patch treatment. In Europe, the product is indicated for the management of peripheral neuropathic pain. Under the agreement, BCWP will be responsible for obtaining marketing authorisation for Qutenza® in South Korea. Upon approval, the company will market and distribute the product. Grünenthal will receive an upfront payment in addition to regulatory and sales-related milestone payments. "We are executing on a dedicated strategy to bring Qutenza® into the Asia-Pacific region to facilitate greater access to non-opioid treatment options for people living with pain and expand the brand's global footprint," says Jan Adams, Chief Commercial Officer (CCO) at Grünenthal. "With BCWP, we have a strong speciality care partner in South Korea, a major market in the Asia-Pacific region, and we are pleased to expand our existing partnership to further progress towards our vision of a World Free of Pain." "Expanding access to innovative, non-opioid treatment options for patients with neuropathic pain is central to our mission of 'Commit to a Better Future for Patients'," says Steve Hong, CEO of BCWorld Pharm. "Our partnership with Grünenthal enables us to introduce Qutenza® to South Korea while further diversifying and strengthening our pain management portfolio." Grünenthal acquired the global rights to Qutenza® in 2018 as part of its M&A-driven growth strategy. Since 2017, Grünenthal has closed successful acquisitions with a total expected deal value of more than €2.3 billion, diversifying its portfolio, enhancing its profitability, and driving business growth. Grünenthal continues to expand the footprint of the acquired brands and to create synergies throughout Grünenthal's infrastructure, including manufacturing, supply, logistics, and commercial activities. About Qutenza ® In Europe, Qutenza is indicated for the treatment of peripheral neuropathic pain in adults, either alone or in combination with other medicinal products for the treatment of pain. For further information, please visit . Qutenza (capsaicin) 8% topical system is approved in the US for the treatment of neuropathic pain associated with postherpetic neuralgia and for the treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet in adults. Important US safety information is available at . About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2024, Grünenthal employed around 4,300 people and achieved revenues of €1.8 billion. More information: Follow us on: LinkedIn: Grunenthal Group | Instagram: grunenthal About BCWorldPharm BCWorld Pharm Co., Ltd. is a KOSDAQ-listed South Korean specialty pharmaceutical company with a strong presence in the domestic pain market. The company is expanding its portfolio through global partnerships, including its recently expanded collaboration on Nucynta®. Under its Vision 2030 strategy, BCWorld Pharm aims to strengthen its leadership in specialty pain care in Korea and beyond." More information: SOURCE Grünenthal Group 21% more press release views with Request a Demo

STOUGHTON, Mass., March 05, 2026 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq: COLL) today announced it will present two posters featuring real-world data from its portfolio of differentiated pain medications at PainConnect 2026, the American Academy of Pain Medicine (AAPM)’s Annual Meeting, taking place in Salt Lake City, Utah from March 5-8, 2026. The presentations highlight real-world clinical insights from Collegium’s pain portfolio and reflect the Company’s continued focus on generating evidence that helps inform everyday practice. “Understanding how therapies perform in real-world settings is essential to informing pain treatment,” said Thomas Smith, M.D., Chief Medical Officer. “These analyses contribute important context that can inform clinical practice and ongoing scientific dialogue.” The poster presentations will take place Friday, March 6, on TV 1 at The Grand America Hotel. BELBUCA ® Time TV Abstract Title Presenter 10:00 – 10:05 AM 1 Abstract #27: Rate and Frequency of Nonmedical Use (NMU) of Buprenorphine Compared to Other Opioids for the Treatment of Pain Jody L. Green, PhD 10:05 – 10:10 AM 1 Abstract #28: Presence of Illicit Drugs in Urine Drug Testing Among Pain Clinic Patients Treated with Buprenorphine or Full Agonist Opioids Jody L. Green, PhD APPROVED USE BELBUCA® (buprenorphine buccal film) CIII is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them. • A long-acting opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death. • Not to be taken on an “as needed” basis. IMPORTANT SAFETY INFORMATION about BELBUCA® WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF BELBUCA Addiction, Abuse, and Misuse Because the use of Belbuca exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Belbuca, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Belbuca are essential. Misuse or abuse of Belbuca by chewing, swallowing, snorting, or injecting buprenorphine extracted from the buccal film will result in the uncontrolled delivery of buprenorphine and pose a significant risk of overdose and death. Accidental Exposure Accidental exposure of even one dose of Belbuca, especially in children, can result in a fatal overdose of buprenorphine. Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Belbuca and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription. Important information about BELBUCA: Get emergency help or call 911 right away if you take too much BELBUCA (overdose). When you first start taking BELBUCA, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. Taking BELBUCA with other opioid medicines, benzodiazepines, gabapentinioids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death. Never give anyone else your BELBUCA. They could die from taking it. Selling or giving away BELBUCA is against the law. Store BELBUCA securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not use BELBUCA if you have: severe asthma, trouble breathing, or other lung problems. a bowel blockage or have narrowing of the stomach or intestines. Before taking BELBUCA, tell your healthcare provider if you have a history of: head injury, seizures heart rhythm problems (long QT syndrome) liver, kidney, thyroid problems pancreas or gallbladder problems problems urinating tooth problems, including a history of cavities abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems Tell your healthcare provider if you are: noticing your pain getting worse. If your pain gets worse after you take BELBUCA, do not take more of BELBUCA without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking BELBUCA. pregnant or planning to become pregnant. Use of BELBUCA for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening I not recognized and treated. breastfeeding. Not recommended during treatment with BELBUCA. It may harm your baby. living in a household where there are small children or someone who has abused street or prescription drugs. taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking BELBUCA with certain other medicines can cause serious side effects and could lead to death. When taking BELBUCA: Do not change your dose. Apply BELBUCA exactly as prescribed by your healthcare provider. Use the lowest effective dose possible for the shortest time needed. See the detailed Instructions for Use for information about how to apply BELBUCA. Do not apply BELBUCA if the package seal is broken or the film is cut, damaged, or changed in any way. After the film has adhered to your cheek, avoid eating or drinking until the film has completely dissolved, usually within 30 minutes. After BELBUCA is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing teeth. Report any problems with your teeth immediately to your healthcare provider and schedule an appointment with a dentist. Tell your dentist that you have started taking BELBUCA. Avoid touching or moving the buccal film with your tongue or fingers. Do not chew, swallow, snort or inject BELBUCA. This will result in uncontrolled delivery of buprenorphine and may cause you to overdose and die. Call your healthcare provider if the dose you are using does not control your pain. Do not stop using BELBUCA without talking to your healthcare provider. Dispose of expired, unwanted, or unused BELBUCA by removing the BELBUCA film from the foil packaging, and promptly flushing down the toilet (if a drug takeback option is not readily available). Visit for additional information on disposal of unused medicines. While using BELBUCA DO NOT: Drive or operate heavy machinery, until you know how BELBUCA affects you. BELBUCA can make you sleepy, dizzy, or lightheaded. Drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with BELBUCA may cause you to overdose and die. The possible side effects of BELBUCA are: nausea, constipation, headache, vomiting, dizziness, and sleepiness. Call your healthcare provider if you have any of these symptoms and they are severe. Get emergency medical help or call 911 right away if you have: trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion. These are not all the possible side effects of BELBUCA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov. Please see full Prescribing Information , including Boxed Warning on Addiction, Abuse, and Misuse, and other serious risks, and Medication Guide or speak to your healthcare provider if you have questions about BELBUCA. About Collegium Pharmaceutical, Inc. Collegium is building a leading, diversified biopharmaceutical company committed to improving the lives of people living with serious medical conditions. The Company has a leading portfolio of responsible pain management medications and a rapidly growing neuropsychiatry business. Collegium’s strategy includes growing its commercial portfolio, with ADHD as the lead growth driver, and deploying capital in a disciplined manner. Collegium’s headquarters are located in Stoughton, Massachusetts. For more information, please visit the Company’s website at Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "forecasts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements related to our 2026 financial guidance, including projected product revenues, adjusted operating expenses and adjusted EBITDA, statements related to the projected launch of the authorized generic versions of Nucynta and Nucynta ER and anticipated shared net profits following the launch of such authorized generic versions, statements related to current and future market opportunities for our products and our assumptions related thereto, expectations (financial or otherwise) and intentions, and other statements that are not historical facts. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results, performance, or achievements to differ materially from the company's current expectations, including risks relating to, among others: unknown liabilities; risks related to future opportunities and plans for our products, including uncertainty of the expected financial performance of such products; our ability to commercialize and grow sales of our products; our ability to manage our relationships with licensors; the success of competing products that are or become available; our ability to maintain regulatory approval of our products, and any related restrictions, limitations, and/or warnings in the label of our products; the size of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the rate and degree of market acceptance of our products; the costs of commercialization activities, including marketing, sales and distribution; changing market conditions for our products; the outcome of any patent infringement or other litigation that may be brought by or against us; the outcome of any governmental investigation related to our business; our ability to secure adequate supplies of active pharmaceutical ingredient for each of our products and manufacture adequate supplies of commercially saleable inventory; our ability to obtain funding for our operations and business development; regulatory developments in the U.S.; our expectations regarding our ability to obtain and maintain sufficient intellectual property protection for our products; our ability to comply with stringent U.S. and foreign government regulation in the manufacture of pharmaceutical products, including U.S. Drug Enforcement Agency compliance; our customer concentration; and the accuracy of our estimates regarding expenses, revenues, capital requirements and need for additional financing. These and other risks are described under the heading "Risk Factors" in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other filings with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. Investor Contacts: Ian Karp Vice President, Investor Relations ir@collegiumpharma.com Danielle Jesse Director, Investor Relations ir@collegiumpharma.com Media Contact: Jessica Cotrone Senior Vice President, Communications & Corporate Affairs communications@collegiumpharma.com