James Tetrud1, Paul Nausieda2, David Kreitzman3, Grace S Liang4, Anette Nieves5, Andrew P Duker6, Robert A Hauser7, Eric S Farbman8, Aaron Ellenbogen9, Ann Hsu10, Sherron Kell11, Sarita Khanna12, Robert Rubens13, Suneel Gupta14. 1. The Parkinson's Institute and Clinical Center, 675 Almanor Ave, Sunnyvale, CA 94085, USA. Electronic address: jtetrud@stanford.edu. 2. Wisconsin Institute for Neurologic and Sleep Disorders, 945 N 12th St, Milwaukee, WI 53233, USA. Electronic address: nausiedamd@parkcent.com. 3. The Parkinson's Disease and Movement Disorders Center of Long Island, 283 Commack Rd, Commack, NY 11725, USA. Electronic address: PDMDCLI@aol.com. 4. The Parkinson's Institute and Clinical Center, 675 Almanor Ave, Sunnyvale, CA 94085, USA. Electronic address: graceliangmd@gmail.com. 5. Munroe Regional Medical Center, 13940 US-441, Lady Lake, FL 32159, USA. Electronic address: Anette_Nieves@munroeregional.com. 6. University of Cincinnati, 2600 Clifton Ave, Cincinnati, OH 45220, USA. Electronic address: dukeraa@ucmail.uc.edu. 7. University of South Florida, 4202 E Fowler Ave, Tampa, FL 33620, USA. Electronic address: rhauser@health.usf.edu. 8. University of Nevada School of Medicine, 1707 W Charleston Blvd, Las Vegas, NV 89102, USA. Electronic address: efarbman@medicine.nevada.edu. 9. Quest Research Institute, 28595 Orchard Lake Rd #301, Farmington Hills, MI 48334, USA. Electronic address: aellenbogen@comcast.net. 10. Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: annhsu@aol.com. 11. Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: skell@impaxlabs.com. 12. Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: skhanna@impaxlabs.com. 13. Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: rrubens@impaxlabs.com. 14. Impax Laboratories, Inc., 31047 Genstar Road, Hayward, CA 94544, USA. Electronic address: sgupta@impaxlabs.com.
Abstract
BACKGROUND: IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and maintain LD concentrations for a prolonged duration in early or advanced Parkinson's disease (PD). METHODS: In this open-label study, patients underwent 6weeks of conversion to IPX066 from their prior controlled-release (CR)±immediate-release (IR) CD-LD therapy and 6months of maintenance (with an additional 6months of IPX066 at some sites). Clinical utility was assessed at both the end of conversion and maintenance. RESULTS: Among 43 patients initiated on IPX066, 33 completed conversion. The mean LD conversion ratio was 1.8 among 30 patients previously on CR plus IR (and 1.5 among 3 previously taking CR alone). The mean IPX066 dosing frequency was 3.5times/day compared with 2.6times/day for CR plus 4.6times/day for IR previously (and 4.7times/day for CR alone). By patient and clinician global improvement ratings after 6-month maintenance, ≥43.8% of patients were much or very much improved from their previous treatment, and ≥68.8% were at least minimally improved. Adverse events were consistent with those reported in prior IPX066 studies. CONCLUSIONS: These results suggest that advanced PD patients using CR CD-LD±IR can be safely converted to IPX066, with high likelihood of achieving a stable regimen, less frequent LD dosing, and improved overall clinical benefit. TRIAL REGISTRATION: Clinicaltrials.govNCT01411137.
BACKGROUND: IPX066 (Rytary®; carbidopa and levodopa [CD-LD] extended-release capsules) was designed to achieve therapeutic LD plasma concentrations within 1h of dosing and maintain LD concentrations for a prolonged duration in early or advanced Parkinson's disease (PD). METHODS: In this open-label study, patients underwent 6weeks of conversion to IPX066 from their prior controlled-release (CR)±immediate-release (IR) CD-LD therapy and 6months of maintenance (with an additional 6months of IPX066 at some sites). Clinical utility was assessed at both the end of conversion and maintenance. RESULTS: Among 43 patients initiated on IPX066, 33 completed conversion. The mean LD conversion ratio was 1.8 among 30 patients previously on CR plus IR (and 1.5 among 3 previously taking CR alone). The mean IPX066 dosing frequency was 3.5times/day compared with 2.6times/day for CR plus 4.6times/day for IR previously (and 4.7times/day for CR alone). By patient and clinician global improvement ratings after 6-month maintenance, ≥43.8% of patients were much or very much improved from their previous treatment, and ≥68.8% were at least minimally improved. Adverse events were consistent with those reported in prior IPX066 studies. CONCLUSIONS: These results suggest that advanced PDpatients using CRCD-LD±IR can be safely converted to IPX066, with high likelihood of achieving a stable regimen, less frequent LD dosing, and improved overall clinical benefit. TRIAL REGISTRATION: Clinicaltrials.govNCT01411137.