SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, announced today that the U.S. Drug Enforcement Administration (DEA) has designated XCOPRI® (cenobamate tablets) as a Schedule V medicine
| PARAMUS, N.J., March 10, 2020 /PRNewswire/ -- SK Life Science, Inc., a subsidiary of SK Biopharmaceuticals Co., Ltd., an innovative global pharmaceutical company focused on developing treatments for central nervous system (CNS) disorders, announced today that the U.S. Drug Enforcement Administration (DEA) has designated XCOPRI® (cenobamate tablets) as a Schedule V medicine. XCOPRI was approved by the U.S. Food and Drug Administration (FDA) on November 21, 2019, for the treatment of partial-onset seizures in adults.
“With the DEA’s decision to designate XCOPRI as a Schedule V medicine, the final step of the regulatory approval process is complete,” said Jeong Woo Cho, PhD, President and CEO of SK Biopharmaceuticals and SK life science. “We are moving forward to launch XCOPRI as planned in the second quarter of 2020 and remain steadfast in our commitment to addressing unmet needs for patients with epilepsy.” Epilepsy is one of the most common neurological disorders and has significant physical and psychosocial impacts on people who are living with this disease.1 Partial-onset seizures, which begin in just one part of the brain, affect approximately 60% of people with epilepsy.1 Of those with partial-onset seizures, 40% have inadequate control of their seizures even after treatment with two anti-epileptic drugs (AEDs) underscoring a need for new treatment options for these patients.2 About XCOPRI® (cenobamate tablets) While the precise mechanism by which XCOPRI exerts its therapeutic effect is unknown, XCOPRI is believed to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents. It is also a positive allosteric modulator of the γ‑aminobutyric acid (GABAA) ion channel. XCOPRI should be initiated at 12.5 mg once-daily and titrated every two weeks; it will be available in six tablet strengths for once-daily dosing: 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg and 200 mg. XCOPRI can be combined with other AEDs or used alone. Additional clinical trials are investigating XCOPRI in other seizure types. IMPORTANT SAFETY INFORMATION AND INDICATION FOR XCOPRI (cenobamate tablets) CV DO NOT TAKE XCOPRI IF YOU:
XCOPRI CAN CAUSE SERIOUS SIDE EFFECTS, INCLUDING: QT shortening: XCOPRI may cause problems with the electrical system of the heart (QT shortening). Call your healthcare provider if you have symptoms of QT shortening including fast heartbeat (heart palpitations) that last a long time or fainting. Suicidal behavior and ideation: Antiepileptic drugs, including XCOPRI, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your health care provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempting to commit suicide; new or worse depression, anxiety, or irritability; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); acting aggressive; being angry or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); or other unusual changes in behavior or mood. Nervous system problems: XCOPRI may cause problems that affect your nervous system. Symptoms of nervous system problems include: dizziness, trouble walking or with coordination, feeling sleepy and tired, trouble concentrating, remembering, and thinking clearly, and vision problems. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XCOPRI affects you. Do not drink alcohol or take other medicines that can make you sleepy or dizzy while taking XCOPRI without first talking to your healthcare provider. DISCONTINUATION: DRUG INTERACTIONS: PREGNANCY AND LACTATION: Talk to your health care provider if you are pregnant or plan to become pregnant. It is not known if XCOPRI will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking XCOPRI. You and your healthcare provider will decide if you should take XCOPRI while you are pregnant. If you become pregnant while taking XCOPRI, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334 or go to www.aedpregnancyregistry.org. Talk to your health care provider if you are breastfeeding or plan to breastfeed. It is not known if XCOPRI passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while taking XCOPRI. COMMON SIDE EFFECTS: These are not all the possible side effects of XCOPRI. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. DRUG ABUSE: INDICATION: It is not known if XCOPRI is safe and effective in children under 18 years of age. About Epilepsy About SK Biopharmaceuticals, Co., Ltd. and SK Life Science, Inc. Both SK Biopharmaceuticals and SK life science are part of SK Group, one of the largest conglomerates in Korea. SK Holdings, the parent company of SK Biopharmaceuticals, continues to enhance its portfolio value by executing long-term investments with a number of competitive subsidiaries in various business areas, including pharmaceuticals and life science, energy and chemicals, information and telecommunication, and semiconductors. In addition, SK Holdings is focused on reinforcing its growth foundations through profitable and practical management based on financial stability, while raising its enterprise value by investing in new future growth businesses. For more information, please visit http://hc.sk.co.kr/en/. XCOPRI® is a registered trademark of SK Biopharmaceuticals, Co., Ltd. Media Contacts: U.S. Media Inquiries Korea Media Inquiries
SOURCE SK Life Science, Inc. |
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