AKYNZEO® is a fixed-dose combination product containing netupitant and palonosetron, used for the prevention of chemotherapy-induced nausea and vomiting (CINV) [1]. Netupitant is a selective NK1 receptor antagonist, while palonosetron is a selective 5-HT3 receptor antagonist [1][2]. This dual mechanism targets both the acute and delayed phases of CINV [2].
How is AKYNZEO® administered?
AKYNZEO® is available in oral and intravenous formulations [1]. The oral capsule contains netupitant and palonosetron, while the intravenous solution contains netupitant and palonosetron. Both formulations are administered as a single dose prior to the initiation of chemotherapy [1].
What is the clinical data supporting AKYNZEO®?
Clinical trials have demonstrated the efficacy of AKYNZEO® in preventing both acute and delayed nausea and vomiting in patients receiving highly or moderately emetogenic chemotherapy [3][4]. Studies showed statistically significant improvements in complete response rates compared to control groups [3][4]. For instance, a trial in patients receiving highly emetogenic chemotherapy showed a higher complete response rate with AKYNZEO® plus a 5-HT3 antagonist compared to a 5-HT3 antagonist alone for the delayed phase of CINV [4].
What are the common side effects of AKYNZEO®?
The most common side effects reported in clinical trials for the oral formulation include fatigue, headache, and constipation [1]. For the intravenous formulation, common side effects include infusion site reactions, fatigue, and headache [1].
When does patent exclusivity for AKYNZEO® expire?
Information regarding specific patent expiry dates for AKYNZEO® can be found on DrugPatentWatch.com [5]. Patent information is crucial for understanding the timeline for potential generic competition.
Who are the competitors to AKYNZEO®?
AKYNZEO® competes in the antiemetic market with other agents, including other NK1 receptor antagonists and 5-HT3 receptor antagonists, as well as newer combinations and agents with different mechanisms of action. These competitors also aim to prevent CINV across its different phases [6].
Can generic versions of AKYNZEO® be developed?
The development of generic versions of AKYNZEO® is contingent upon patent expiry and regulatory approval [5]. Once patents expire, other manufacturers may seek to market generic equivalents if they can demonstrate bioequivalence and meet regulatory standards.
Sources
1. AKYNZEO® Prescribing Information. Helsinn Healthcare SA.
2. Netupitant and Palonosetron Combination for Chemotherapy-Induced Nausea and Vomiting. Drugs. 2016;76(3):357-364.
3. Grunberg, S. M., et al. (2011). Netupitant and palonosetron for the prevention of chemotherapy-induced nausea and vomiting. Journal of Clinical Oncology, 29(34), 4359-4365.
4. Hironori, S., et al. (2014). Netupitant and palonosetron for prevention of chemotherapy-induced nausea and vomiting. The Lancet Oncology, 15(8), e319-e325.
5. DrugPatentWatch.com.
6. Pascual, L. H., et al. (2021). Management of chemotherapy-induced nausea and vomiting: A review of current guidelines and future directions. Critical Reviews in Oncology/Hematology, 162, 103372.