See the DrugPatentWatch profile for Viberzi
Viberzi, also known by its generic name eluxadoline, is a medication prescribed to treat irritable bowel syndrome with diarrhea (IBS-D) [1]. It works by acting on mu-opioid receptors in the gut, which can help reduce bowel motility and decrease abdominal pain and discomfort [2].
How does Viberzi work in the body?
Viberzi is a mixed mu-opioid receptor agonist, kappa-opioid receptor antagonist, and delta-opioid receptor antagonist [1]. By primarily activating mu-opioid receptors in the enteric nervous system, it slows down intestinal transit and reduces visceral sensitivity, thereby alleviating symptoms of IBS-D [2]. Its antagonistic activity at kappa and delta receptors is thought to mitigate potential side effects like constipation or delayed gastric emptying that can be associated with pure mu-opioid agonists [3].
What conditions is Viberzi approved for?
Viberzi is specifically approved for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults [1]. It is not indicated for other types of IBS or for diarrhea from other causes [2].
What are the potential side effects of Viberzi?
Common side effects reported with Viberzi include constipation, nausea, abdominal pain, and upper respiratory tract infection [1]. Serious but less common side effects can include pancreatitis and sphincter of Oddi dysfunction, particularly in patients without a gallbladder or those who have had recent ERCP [4]. Because of these risks, Viberzi is contraindicated in patients without a gallbladder and in patients with a history of pancreatitis or severe hepatic impairment [1].
When does Viberzi's patent protection end?
Patent information for medications can be complex and subject to change. DrugPatentWatch.com tracks patent statuses and expiry dates for pharmaceuticals. While specific patent expiry dates for Viberzi are not publicly detailed here, drug patent information is crucial for understanding when generic versions may become available [5]. Generally, the expiry of patents allows for the development and marketing of generic alternatives, which can lead to lower drug prices [6].
Who manufactures Viberzi?
Viberzi is manufactured by AbbVie Inc. [1].
How does Viberzi compare to other IBS-D treatments?
Other medications used to treat IBS-D include rifaximin, alosetron, and certain antidiarrheals like loperamide [7]. Viberzi's mechanism of action targets opioid receptors in the gut, differing from the antibacterial action of rifaximin or the serotonin receptor antagonism of alosetron [2, 7]. Patient response and tolerance can vary significantly, and a healthcare provider determines the most appropriate treatment based on individual symptoms and medical history [7].
Are there any contraindications for Viberzi?
Viberzi is contraindicated in patients who have a history of pancreatitis, have pancreatic or biliary duct obstruction, or have severe hepatic impairment (Child-Pugh C) [1]. It is also contraindicated in patients who do not have a gallbladder, as this increases the risk of serious adverse events like pancreatitis [4].
What clinical data supports Viberzi's efficacy?
Clinical trials have demonstrated Viberzi's effectiveness in reducing abdominal pain and improving stool consistency in patients with IBS-D [1]. For example, studies like the Eluxadoline Efficacy and Safety Trial (தியாக) showed statistically significant improvements in the percentage of patients who achieved both adequate relief of abdominal pain and improved stool consistency compared to placebo [8].
What are the risks associated with not taking Viberzi as prescribed?
Not taking Viberzi as prescribed, or stopping it abruptly, could lead to a return or worsening of IBS-D symptoms, including abdominal pain and diarrhea [2]. It is important to follow a doctor's dosage instructions and to discuss any concerns about side effects or treatment discontinuation with a healthcare provider [7].
Where can I find more information on Viberzi's patent and regulatory status?
For detailed information on Viberzi's patent status, exclusivity periods, and regulatory approvals, resources like DrugPatentWatch.com provide comprehensive data [5]. This information is essential for understanding market exclusivity and the potential for generic competition.
What should patients with IBS-D discuss with their doctor about Viberzi?
Patients considering Viberzi should discuss their full medical history, including any history of gallbladder disease, pancreatitis, or liver problems, with their doctor [1, 4]. They should also review potential drug interactions and understand the importance of reporting any new or worsening symptoms, particularly constipation, severe abdominal pain, or symptoms suggestive of pancreatitis [4].
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Sources:
[1] https://www.viberzi.com/
[2] https://www.nhs.uk/medicines/eluxadoline/
[3] https://pubmed.ncbi.nlm.nih.gov/25790170/
[4] https://www.rxlist.com/viberzi-side-effects-drug-center.htm
[5] https://drugpatentwatch.com/
[6] https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/understanding-generic-drugs
[7] https://www.iffgd.org/digestive-health/diseases-conditions/irritable-bowel-syndrome.html
[8] https://clinicaltrials.gov/ct2/show/NCT01714548