Boehringer Ingelheim wish to announce that new Mirapexin (pramipexole) prolonged-release, once daily tablet has been granted marketing authorisation by the European Commission in all EU/EEA countries for the treatment of early and advanced idiopathic Parkinson’s disease (PD).
Pramipexole has been indicated since 1997 (as an immediate-release tablet) for the treatment of the signs and symptoms of early and advanced idiopathic Parkinson’s disease, as monotherapy or in combination with levodopa. Approval of the Mirapexin prolonged-release once daily tablet for the treatment of early and advanced PD was based on the submission of clinical trial results showing that the new formulation can offer an efficacy and safety profile comparable to the immediate-release tablet taken three times daily.
In addition to clinical trial results that confirm the therapeutic benefits of the new prolonged release formulation administered in a once-a-day regimen, a further trial has shown that patients already taking Mirapexin immediate-release tablets may easily be switched overnight to the Mirapexin prolonged-release tablet, at the same daily dose.
Efficacy of Mirapexin prolonged-release in both early and advanced PD
The safety and efficacy of Mirapexin prolonged-release tablets in the treatment of PD was evaluated in a multinational drug development program consisting of several randomised, controlled trials.
• One trial including a total of 539 patients with early PD showed that:
Superiority of Mirapexin prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (CGI-I and PGI-I responder rates) efficacy endpoints. Maintenance of efficacy was shown in patients treated for 33 weeks. Mirapexin prolonged-release tablets were non-inferior to pramipexole immediate release tablets as assessed on the UPDRS Parts II+III score at week 33.
• One trial including a total of 517 patients with advanced PD who were on concomitant levodopa therapy showed that:
Superiority of Mirapexin prolonged-release tablets over placebo was demonstrated after 18 weeks of treatment on both the primary (UPDRS Parts II+III score) and the key secondary (off-time) efficacy endpoints.
Efficacy and tolerability of overnight switch to Mirapexin prolonged-release
The efficacy and tolerability of an overnight switch from Mirapexin tablets to Mirapexin prolonged-release tablets at the same daily dose were evaluated in a 9 week double-blind clinical study. This randomised study included 156 patients with early PD on stable dose of Mirapexin immediate release (2.7mg/day +/-0.9).
Efficacy was maintained in 84.5% of patients switched to Mirapexin prolonged-release tablets. Out of these patients, 82.8% did not change their dose, 13.8% increased and 3.4% decreased their dose.
In half of the 16 patients who did not meet the criterion for maintained efficacy on UPDRS Part II+III score, the change from baseline was considered not clinically relevant. Only one patient switched to Mirapexin prolonged-release tablets experienced a drug-related adverse event leading to withdrawal.
Conclusion
Mary Baker, MBE, President of the European Federation of Neurological Associations (EFNA) commented on the European approval of the new formulation: “Most people with Parkinson’s disease take many different pills on a daily basis, to manage their PD symptoms and other concomitant conditions. Being able to reduce their pill burden without foregoing the effectiveness will be welcomed by patients as well as by their care givers as it is expected that a once-daily administration can improve patient adherence to their treatment regimen.”
“We are very pleased that due to the robust evidence base, the regulatory review experienced no delay, which will allow the first European countries to already make the once daily tablet available to patients,” said Dr. Manfred Haehl, MD, Senior Vice-President Medicine at Boehringer Ingelheim Corporate Headquarters. “In addition, the data show that the prolonged-release Mirapexin tablet causes less frequent fluctuations in the plasma concentration over 24 hours compared to the three times daily administration of the immediate release tablet, an important aspect for physicians when choosing the best treatment option for their patient.”
Full prescribing information and references available from Boehringer Ingelheim Ireland Ltd. Telephone: (01)2959620.
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