Triptorelin Embonate (6-Month Formulation)
- 147 Downloads
A 6-month formulation of the gonadotropin-releasing hormone agonist triptorelin embonate (designed to deliver 22.5 mg of triptorelin over a 6-month period) has been developed for use in the treatment of advanced prostate cancer.
Following intramuscular administration of the 6-month formulation of triptorelin embonate 22.5 mg to men with advanced prostate cancer (subset of 15 patients from the pivotal clinical trial), serum testosterone levels initially increased, followed by a rapid, sustained decrease. Castrate serum testosterone levels (i.e. ≤1.735nmol/L) wereachieved in a geometric mean time of 18.8 days.
The 6-month formulation of triptorelin embonate achieved and maintained castrate serum testosterone levels in patients with advanced prostate cancer (n= 120), according to the results of the pivotal, non-comparative, multicentre trial (patients received intramuscular triptorelin embonate 22.5 mg on day 1 and at month 6 [week 24]). By day 29, 97.5% of patients had castrate serum testosterone levels. Castrate serum testosterone levels were maintained from months 2 to 12 in 93.0% of patients. Prior to the second injection at month 6, 98.3% of patients had castrate serum testosterone levels, and 98.3% of patients had castrate serum testosterone levels at study completion.
The 6-month formulation of triptorelin embonate 22.5 mg was generally well tolerated in patients with advanced prostate cancer; adverse events were of mild severity in the majority of patients. Drug-related adverse events (e.g. hot flushes) were consistent with the pharmacological action of triptorelin. Injection-site reactions occurred in 6.7% of triptorelin embonate recipients.
Acknowledgements and Disclosures
The manuscript was reviewed by: C.F. Heyns, Departement Urologie, Universiteit Stellenbosch en Tygerberg-hospitaal, Tygerberg, South Africa; H. Isbarn, University Hospital Hamburg-Eppendorf, Department of Urology, Hamburg, Germany.
The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on this article. Changes resulting from comments received were made on the basis of scientific and editorial merit.
- 2.Horwich A, Parker C, Kataja V. Prostate cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2008; 19 Suppl. 2: 45–6Google Scholar
- 4.National Institute for Health and Clinical Excellence. Prostate cancer: diagnosis and treatment [online]. Available from URL: http://www.nice.org.uk/nicemedia/pdf/CG58FullGuideline.pdf [Accessed 2009 Dec 8]
- 8.National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology™: prostate cancer v.2.2009 [online]. Available from URL: http://www.nccn.org/professionals/physician_gls/PDF/prostate.pdf [Accessed 2009 Dec 9]
- 13.Ipsen. Ipsen’s Decapeptyl® 6-month formulation receives marketing authorization in France for the treatment of locally advanced or metastatic prostate cancer [media release]. Available from URL: http://www.ipsen.com/articles/mediacentre/pressreleases/20091113___amm_decapeptyl_france_10.pdf [Accessed 2009 Dec 10]
- 14.Ipsen. Ipsen and Debiopharm Group announce that Decapeptyl® (triptorelin embonate) 6-month successfully completes the European decentralised procedure for the treatment of locally advanced or metastatic prostate cancer [media release; online]. Available from URL: http://www.ipsen.com/articles/mediacentre/pressreleases/20091013___decapeptyl_6_months_10.pdf [Accessed 2009 Dec 10]
- 15.European Medicines Agency. Triptorelin 22.5 mg: summary of product characteristics. 2009Google Scholar
- 20.Debiopharm S.A. Clinical study report: a multicentre, open, non-comparative, phase III study on the efficacy, pharmacokinetics and safety of two injections of triptorelin embonate 22.5 mg 6-month formulation in patients with advanced prostate cancer. Debiopharm S.A., 2008 May. (Data on file)Google Scholar