MOVANTIK (naloxegol) Tablets has been descheduled as a controlled substance by the DEA. Following this ruling, AstraZeneca submitted a request from the FDA for an immediate update to the MOVANTIK label to remove the controlled substance designation.
This step was necessary after it was approved in September 16, 2014, as a controlled substance due to its structural relatedness to noroxymorphone. However, during the review of the New Drug Application (NDA), the US Food and Drug Administration (FDA) evaluated the abuse potential of MOVANTIK and the approved labeling confirms that MOVANTIK has no risk of abuse or dependency.
MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.1 OIC is one of the most common side effects of opioids.2,3
MOVANTIK was approved as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of OIC in adult patients with chronic, non-cancer pain.1
AstraZeneca is committed to taking the next steps to make MOVANTIK available to physicians and their patients in the first half of 2015.
Important Safety Information for MOVANTIK
MOVANTIK is contraindicated in:
º Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction due to the potential for GI perforation
º Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
º Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
• Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
• Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone in the clinical trials were observed to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients
• The most common adverse reactions with MOVANTIK in clinical trials were abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)
Please see full US Prescribing Information
http://www.azpicentral.com/movantik/movantik.pdf
References
1. Prescribing Information for MOVANTIK. AstraZeneca Pharmaceuticals LP, Wilmington, DE
2. Panchal SJ et al. Int J Clin Pract. 2007;61(7):1181-1187.
3. Kalso, et al. Pain. 2004;112:372-3803
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This step was necessary after it was approved in September 16, 2014, as a controlled substance due to its structural relatedness to noroxymorphone. However, during the review of the New Drug Application (NDA), the US Food and Drug Administration (FDA) evaluated the abuse potential of MOVANTIK and the approved labeling confirms that MOVANTIK has no risk of abuse or dependency.
MOVANTIK is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.1 OIC is one of the most common side effects of opioids.2,3
MOVANTIK was approved as the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication for the treatment of OIC in adult patients with chronic, non-cancer pain.1
AstraZeneca is committed to taking the next steps to make MOVANTIK available to physicians and their patients in the first half of 2015.
Important Safety Information for MOVANTIK
MOVANTIK is contraindicated in:
º Patients with known or suspected gastrointestinal (GI) obstruction and patients at increased risk of recurrent obstruction due to the potential for GI perforation
º Patients receiving strong CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole) because these medications can significantly increase exposure to naloxegol which may precipitate opioid withdrawal symptoms
º Patients with a known serious or severe hypersensitivity reaction to MOVANTIK or any of its excipients
• Cases of GI perforation have been reported with the use of another peripherally acting opioid antagonist in patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract. Monitor for severe, persistent, or worsening abdominal pain; discontinue if this symptom develops
• Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, irritability, and yawning, occurred in patients treated with MOVANTIK. Patients receiving methadone in the clinical trials were observed to have a higher frequency of GI adverse reactions that may have been related to opioid withdrawal than patients receiving other opioids. Patients with disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal or reduced analgesia. Monitor for symptoms of opioid withdrawal when using MOVANTIK in such patients
• The most common adverse reactions with MOVANTIK in clinical trials were abdominal pain (21%), diarrhea (9%), nausea (8%), flatulence (6%), vomiting (5%), headache (4%), and hyperhidrosis (3%)
Please see full US Prescribing Information
http://www.azpicentral.com/movantik/movantik.pdf
References
1. Prescribing Information for MOVANTIK. AstraZeneca Pharmaceuticals LP, Wilmington, DE
2. Panchal SJ et al. Int J Clin Pract. 2007;61(7):1181-1187.
3. Kalso, et al. Pain. 2004;112:372-3803
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