IPX066: A novel carbidopa-levodopa extended-release formulation

Expert Review of Neurotherapeutics

Volumn 12, Issue 2, 2012, Pages 133-140

  Hauser, Robert A ^a  

^a UNIVERSITY OF SOUTH FLORIDA   (United States)

Author keywords

carbidopa; dyskinesia; extended release; fluctuations; Impax; IPX066; levodopa; medication; Parkinson's disease; treatment

Indexed keywords

CARBIDOPA; CARBIDOPA PLUS LEVODOPA; IPX 066; LEVODOPA; PLACEBO; UNCLASSIFIED DRUG;

ANXIETY; AREA UNDER THE CURVE; DISEASE SEVERITY; DIZZINESS; DRUG ABSORPTION; DRUG EFFECT; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DYSKINESIA; FALLING; FATIGUE; HEADACHE; HUMAN; INSOMNIA; MAXIMUM PLASMA CONCENTRATION; MENTAL DISEASE; MORNING DOSAGE; NAUSEA; PARKINSON DISEASE; PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; SINGLE DRUG DOSE; SOMNOLENCE; SUSTAINED DRUG RELEASE;

ANTIPARKINSON AGENTS; CARBIDOPA; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; HUMANS; LEVODOPA; PARKINSON DISEASE;

EID: 84856590670     PISSN: 14737175     EISSN: 17448360     Source Type: Journal    
DOI: 10.1586/ern.11.195     Document Type: Review

References (28)

1. Olanow CW, Obeso JA, Stocchi F. Continuous dopamine-receptor treatment of Parkinson's disease: scientific rationale and clinical implications. Lancet Neurol. 5, 677-687 (2006). dopaminergic stimulation hypothesis and the evidence for it. (Pubitemid 44081890)
2. Deleu D, Northway MG, Hanssens Y. Clinical pharmacokinetic and pharmacodynamic properties of drugs used in the treatment of Parkinson's disease. Clin. Pharmacokinet. 41, 261-309 (2002). (Pubitemid 34533757)
3. Rascol O, Brooks DJ, Korczyn AD, De Deyn PP, Clarke CE, Lang AE. A five-year study of the incidence of dyskinesia in patients with early Parkinson's disease who were treated with ropinirole or levodopa. 056 Study Group. N. Engl. J. Med. 342, 1484-1491 (2000). (Pubitemid 30318272)
4. Holloway RG, Shoulson I, Fahn S, et al. Pramipexole vs levodopa as initial treatment for Parkinson disease: a 4-year randomized controlled trial. Arch. Neurol. 61, 1044-1053 (2004). (Pubitemid 38915945)
5. Stocchi F, Vacca L, Ruggieri S, Olanow CW. Intermittent vs continuous levodopa administration in patients with advanced Parkinson disease: a clinical and pharmacokinetic study. Arch. Neurol. 62, 905-910 (2005). (Pubitemid 40973452)
6. Hauser RA. Levodopa: past, present, and future. Eur. Neurol. 62, 1-8 (2009).
7. Hammerstad JP, Woodward WR, Nutt JG, Gancher ST, Block GA, Cyhan G. Controlled release levodopa/carbidopa 25/100 (Sinemet CR 25/100): pharmacokinetics and clinical efficacy in untreated parkinsonian patients. Clin. Neuropharmacol. 17, 429-434 (1994). (Pubitemid 24294469)
8. Hauser RA. Levodopa/carbidopa/entacapone (Stalevo). Neurology 62(1, Suppl. 1), S64-S71 (2004). (Pubitemid 38082854)
9. LeWitt PA, Jennings D, Lyons KE, et al. Pharmacokinetic-pharmacodynamic crossover comparison of two levodopa extension strategies. Mov. Disord. 24, 1319-1324 (2009).
10. Samanta J, Hauser RA. Duodenal levodopa infusion for the treatment of Parkinson's disease. Expert Opin. Pharmacother. 8, 657-664 (2007). (Pubitemid 46547018)
11. Hauser RA. Future treatments for Parkinson's disease: surfing the PD pipeline. Int. J. Neurosci. 121(Suppl. 2), 53-62 (2011). investigational treatments in development for Parkinson's disease (PD).
12. Manson AJ, Turner K, Lees AJ. Apomorphine monotherapy in the treatment of refractory motor complications of Parkinson's disease: long-term follow-up study of 64 patients. Mov. Disord. 17, 1235-1241 (2002). (Pubitemid 36041337)
13. Hauser RA, Ellenbogen AL, Metman LV et al. Crossover comparison of IPX066 and a standard levodopa formulation in advanced Parkinson's disease. Mov. Disord. 26, 2246-2252 (2011).
14. Hauser RA, Nausieda P, Ondo W, et al. Double-blind, controlled trial of IPX066, a novel carbidopa-levodopa extended-release formulation, in advanced Parkinson's disease (ADVANCE-PD trial). Presented at: Movement Disorder Society Meeting 2011. Toronto, ON, Canada, 5-7 June 2011 (Abstract LB9).
15. Pahwa R, Ellenbogen A, Jankovic J, Hauser R, Fahn S; Clinical Team at Impax Pharmaceuticals. Efficacy and safety of IPX066, a new carbidopa-levodopa (CD- LD) extended-release formulation, in LD-naive early Parkinson's disease (APEX-PD trial). Mov. Disord. 26(Suppl. 2), S137 (2011).
16. Hauser RA, Deckers F, Lehert P. Parkinson's disease home diary: further validation and implications for clinical trials. Mov. Disord. 19, 1409-1413 (2004). (Pubitemid 40104047)
17. Hauser RA, Auinger P; Parkinson Study Group. Determination of minimal clinically important change in early and advanced Parkinson's disease. Mov. Disord. 26, 813-818 (2011).
18. Stocchi F, Rascol O, Kieburtz K, et al. Initiating levodopa/carbidopa therapy with and without entacapone in early Parkinson disease: the STRIDE-PD study. Ann. Neurol. 68, 18-27 (2010). Erratum in: Ann. Neurol. 68, 412-413 (2010).
19. Hauser RA, McDermott MP, Messing S. Factors associated with the development of motor fluctuations and dyskinesias in Parkinson disease. Arch. Neurol. 63, 1756-1760 (2006). (Pubitemid 44925085)
20. Olanow CW, Rascol O, Hauser R, et al.; ADAGIO Study Investigators. A double-blind, delayed-start trial of rasagiline in Parkinson's disease. N. Engl. J. Med. 361, 1268-1278 (2009). Erratum in: N. Engl. J. Med. 364, 1882 (2011).
21. Hauser RA, Lew MF, Hurtig HI, Ondo WG, Wojcieszek J, Fitzer-Attas CJ; TEMPO Open-label Study Group. Long-term outcome of early versus delayed rasagiline treatment in early Parkinson's disease. Mov. Disord. 24, 564-573 (2009).
22. Pålhagen S, Heinonen E, Hägglund J, Kaugesaar T, Mäki-Ikola O, Palm R; Swedish Parkinson Study Group. Selegiline slows the progression of the symptoms of Parkinson disease. Neurology 66, 1200-1206 (2006). (Pubitemid 43739704)
23. The Micheal J Fox Foundation for Parkinson's Disease. Searchable database of funded grants. www.michaeljfox.org/research- MJFFfundingPortfolio- searchableAwardedGrants-3. cfm?ID=225&#Update-1 (Accessed 16 October 2011)
24. GSK announces positive topline results of Phase III study of IPX066 in advanced Parkinson's disease. www.gsk.com/media/pressreleases/2011/2011- pressrelease-10040.htm (Accessed 16 October 2011)
25. An open-label extension study of the safety and clinical utility of IPX066 in subjects with Parkinson's. http://clinicaltrials.gov/ct2/show/ NCT01096186?term=IPX066&rank=1 (Accessed 14 December 2011)
26. A study to compare IPX066 and carbidopa/levodopa/entacapone (CLE) followed by an open-label safety study of IPX066 (CLE with OLE). http://clinicaltrials.gov/ct2/show/NCT01130493?term=IPX066&rank=2 (Accessed 14 December 2011)
27. Impax Pharmaceuticals. Product pipeline. www.impaxpharma.com/rd-focus/ product-pipeline (Accessed 16 October 2011)
28. XenoPort announces XP21279 Phase 2 clinical trial results in patients with advanced Parkinson's disease. http://phx.corporate-ir.net/phoenix.zhtml? c=187883&p=RssLanding&cat=news&id=1636005 (Accessed 16 December 2011)