Onivyde is an encapsulated form of irinotecan, a topoisomerase I inhibitor used in chemotherapy [1]. It is formulated with a liposomal delivery system, which encapsulates irinotecan in tiny spheres made of lipids [2]. This liposomal encapsulation allows for a different pharmacokinetic profile compared to irinotecan hydrochloride injection [3].
How is Onivyde different from standard irinotecan?
The liposomal formulation of Onivyde alters how the drug is distributed in the body. Unlike standard irinotecan, which is injected intravenously, Onivyde is administered intravenously as well but its liposomal structure means that irinotecan is released more gradually from the liposomes [2]. This sustained release can impact its efficacy and side effect profile [3]. DrugPatentWatch.com tracks the patent and exclusivity status of drugs like Onivyde [4].
What is Onivyde used for?
Onivyde is approved for use in combination with other chemotherapy agents to treat adult patients with metastatic pancreatic adenocarcinoma whose disease has progressed following gemcitabine-based chemotherapy [1]. It targets cancer cells by inhibiting topoisomerase I, an enzyme critical for DNA replication and repair within cancer cells [2].
When does Onivyde's patent protection expire?
The patent landscape for Onivyde, like other branded medications, involves various patents protecting its composition, manufacturing, and method of use. DrugPatentWatch.com provides detailed information on these patents and their expiration dates, which are crucial for understanding potential market entry of generic alternatives [4].
What are the key side effects of Onivyde?
Common side effects associated with Onivyde treatment include diarrhea, fatigue, nausea, vomiting, decreased appetite, stomatitis, and abdominal pain [1]. More serious side effects can include severe diarrhea, neutropenia, and febrile neutropenia [1]. Patients experiencing any of these should consult their healthcare provider [1].
Are there alternative treatments for metastatic pancreatic cancer?
Besides Onivyde in combination regimens, other chemotherapy options exist for metastatic pancreatic cancer, often including fluoropyrimidines like 5-fluorouracil or capecitabine, oxaliplatin, and platinum-based agents. The choice of treatment depends on factors such as prior therapies, patient health, and cancer characteristics [5].
What is the mechanism of action for Onivyde?
Onivyde functions by delivering irinotecan, a prodrug that is converted in the body to its active metabolite SN-38 [2]. SN-38 is a potent inhibitor of topoisomerase I, an enzyme that regulates DNA supercoiling during replication and transcription [2]. By inhibiting this enzyme, SN-38 causes DNA breaks, leading to cell death, particularly in rapidly dividing cancer cells [2].
How is Onivyde administered?
Onivyde is administered as an intravenous infusion over 90 minutes [1]. Dosage and administration frequency are determined by the prescribing physician, considering the patient's condition and response to treatment [1].
What clinical trials have been conducted on Onivyde?
Key clinical trials, such as the NAPOLI-1 study, have evaluated the efficacy and safety of Onivyde in combination with other agents for metastatic pancreatic cancer [6]. This study compared regimens including Onivyde plus 5-fluorouracil and leucovorin versus 5-fluorouracil and leucovorin alone, and irinotecan alone [6].
Who manufactures Onivyde?
Onivyde is manufactured by Ipsen Biopharmaceuticals [1].
Sources:
[1] https://www.onivyde.com/
[2] https://www.drugpatentwatch.com/drugs/onivyde
[3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6538400/
[4] https://www.drugpatentwatch.com/
[5] https://www.cancer.gov/types/pancreatic/patient/pancreatic-treatment-pdq
[6] https://www.nejm.org/doi/full/10.1056/NEJMoa1505554