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FDA-approved QDOLO (tramadol hydrochloride), an oral liquid, accommodates dosing flexibility, precise titration
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Sep 08, 2020, 09:00 ET
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ATHENS, Ga., Sept. 8, 2020 /PRNewswire/ — Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved QDOLO™ (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
According to the Centers for Disease Control and Prevention, 50 million adults in the United States have chronic daily pain, with 19.6 million adults experiencing high-impact chronic pain that interferes with daily life or work activities. A May, 2019 U.S. Department of Health and Human Services report on pain management best practices emphasized the need for an "individualized, patient-centered" approach for the treatment of pain.1
"As an oral liquid, QDOLO gives physicians flexibility to titrate dosing precisely according to individual patients’ needs," said Jeff Bryant, President and CEO of Athena Bioscience. "In addition, for patients with swallowing disfunction (dysphagia) or who simply have trouble swallowing pills, QDOLO provides an essential alternative to other forms of tramadol." QDOLO has a patent pending.
QDOLO (NDC: 71511-301-16) will be available at chain, independent, and specialty pharmacies.
IMPORTANT SAFETY INFORMATION
QDOLO IMPORTANT SAFETY INFORMATION (ISI)
WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, and MISUSE; RISK EVALUATION and MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF TRAMADOL and OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
QDOLO is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve QDOLO for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):
DOSAGE AND ADMINISTRATION
WARNINGS AND PRECAUTIONS
The most common adverse events (≥15.0%) in patients were dizziness/vertigo, nausea, constipation, headache, somnolence, vomiting and pruritus.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Athena Bioscience, LLC at 1-833-874-2664.
See Full Prescribing Information for all adverse reactions associated with QDOLO.
QDOLO use with Agonist/Antagonist and Partial Agonist Opioid Analgesics should be avoided as it may reduce analgesic effect of QDOLO or precipitate withdrawal symptoms.
See Full Prescribing Information for all drug interactions associated with QDOLO.
Pregnancy and Lactation: May cause fetal harm; breastfeeding is not recommended.
See Full Prescribing Information for use in specific populations associated with QDOLO.
Please see full Prescribing Information for QDOLO https://athenabioscience.com/qdolo-prescribing-infomation/
ABOUT ATHENA BIOSCIENCE
Athena Bioscience, LLC is a specialty pharmaceutical company that seeks to enhance medical options for both healthcare professionals and patients through innovative solutions to unmet challenges. The company endeavors to address unmet needs by optimizing the usefulness of proven pharmaceutical therapies and delivering quality of life improvement to patients. For additional information about Athena Bioscience, LLC, please contact the company at 833-284-3622, or visit athenabioscience.com.
1. U.S. Department of Health and Human Services (2019, May). Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health and Human Services website: https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html
SOURCE Athena Bioscience, LLC
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US FDA Approves Athena Bioscience's New Drug Application (NDA) for QDOLO™ (tramadol hydrochloride) Oral Solution – PRNewswire
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