#rolapitant

ROLAPITANT HYDROCHLORIDE

Rolapitant HCl

Rolapitant hydrochloride

Sch 619734

SCH619734

UNII-57O5S1QSAQ

(5S ,8S)-8-[[(1R)-1-[3 ,5- Bis(trifluoromethyl)phenyl] ethoxy] methyl]-8-phenyl-1,7- diazaspiro[4.5]decan-2-one hydrochloride monohydrate.

CAS 914462-92-3

Empirical Formula: C25H26F6N2O2 · HCl · H2O, Molecular Weight:  555

USAN Name: Rolapitant hydrochloride, INN Name:  rolapitantum or rolapitant

Nausea and vomiting are the two most common side effects associated with cancer chemotherapy, and are referred to as chemotherapy induced nausea and vomiting (CINV).  CINV significantly affects the treatment of patients undergoing chemotherapy. Two major subtypes of CINV are acute CINV (occurs within 24 hours of chemotherapy) and delayed CINV (occurs between 24 hours and five days after treatment). Aloxi (palonosetron), Zofran generic (ondansetron), Kytril generic (granisetron), Emend (aprepitant) and Akynzeo (netupitant-palonosetron FDC) are the examples of currently available drugs to manage both CINV subtypes. In coming years, the CINV drugs market is expected to witness the introduction of two new drugs, namely, SUSTOL (extended release generic granisetron) and rolapitant.

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The world is witnessing a continuous rise in the incidence of various types of cancer, which results in increasing number of patients undergoing chemotherapy. According to the online cancer database GLOBOCAN by the International Agency for Research on Cancer (IARC), globally 14.1 million people were diagnosed with cancer (excluding non-melanoma skin cancer) in 2012 as compared to 12.7 million in 2008. The incidence rate is projected to reach 15.2 million and 17.1 million in 2015 and 2020, respectively. These facts indicate that growing incidence of various types of cancer is likely to induce oncologists to prescribe chemotherapy to their patients for the effective treatment of cancer, thereby driving the CINV drugs market. Usually 25% to 30% patients with cancer receive chemotherapy as a treatment option and 70% to 80% of these patients undergoing chemotherapy exhibit nausea and vomiting as major symptoms.

The approval of new drugs such as rolapitant and SUSTOL (APF-530) would also drive the growth of the CINV drugs market during the forecast period from 2014 to 2020. These pipeline drugs have shown better efficacy than existing drugs during their clinical study. Therefore, the anticipated launch of these more efficacious pipeline drugs during the projected period is likely to encourage physicians to prescribe these new drugs over existing drugs. However, the patent expiry of leading drugs Aloxi and Emend are expected to have significant impact on the revenue of overall CINV drugs market during the forecast period from 2014 to 2020.

North America was the largest regional market for CINV drugs in 2013 in terms of revenue and is expected to retain its position throughout the forecast period, primarily due to the anticipated approval of rolapitant and SUSTOL in 2015 and 2016, respectively. Europe represented the second largest market for CINV drugs after North America in 2013. The launch of CINV pipeline drugs in Europe is expected to be a year later than in North America, given the delays on the past launches of CINV drugs such as Aloxi and Emend. The high incidence of various types of cancer in Asia-Pacific and Rest of the World (RoW) represents both these regions as potential markets for CINV drugs. The economic emergence of countries such as India and China, along with their continuously improving health care infrastructure, is expected to play a key role in driving the CINV market growth in Asia-Pacific region.

FDA approves new drug treatment for nausea and vomiting from chemotherapy

FDA approves new drug treatment for nausea and vomiting from chemotherapy 09/02/2015 09:38 AM EDT   The U.S. Food and Drug Administration approved September 2, 2015 Release The U.S. Food and Drug Administration approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). Varubi is approved in adults in combination with other drugs (antiemetic agents)…