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Articles

Advising on missed or delayed doses of medicines

15 October 2021Guidance to advise people who occasionally forget or are late in taking a dose of their medicine(s).
Search Articles

Medicine Compliance Aid Stability

StalevoOrion Pharma UK Ltd

Orion Pharma UK Ltd
Stalevo
Tablets f/c
A1 · Amber 1Stability data is available in an alternative container (not CAs) that may be extrapolated to support storage in CAs.
No special precautions for storage
No special precautions for storage
26 October 2015

StanekTeva UK

Teva UK
Stanek
Tablets f/c various strenths
A2 · Amber 2No stability data is available, the manufacturer does not, or cannot recommend use in CAs but there are no theoretical concerns with the product.
No special precautions for storage
No special precautions for storage
26 October 2015

New Medicines

Lecigon Advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia

Information

Lecigon
New formulation
Britannia
LobSor Pharmaceuticals

Development and Regulatory status

Pre-registration (Filed)
Launched
None
May 21Currently pre-registration in the UK [5].
Oct 20STADA announces it has already sought regulatory approval via Europe ’s mutual recognition process in several key European countries and anticipates making further filings in the near future [4].
Oct 19STADA Arzneimittel (parent company of LobSor and Britannia) announces that infusion of levodopa, carbidopa and entacapone is approved in Denmark, Norway and Finland, and the company is submitting approval applications to launch the therapy in other major European countries over the next 18 months [3].
Oct 18Lecigon approved for symptomatic treatment of advanced Parkinsons disease in Sweden [3].
Nov 15LobSor announces it is preparing for a pre-IND meeting with the FDA to discuss the commercialisation pathway in the US [3].
Launched in Germany, Austria, Netherlands, Slovenia and Romania [6].

Category

A fixed dose combination of carbidopa, entacapone and levodopa formulated as a gel, for continuous intestinal administration through the duodenal or upper jejunal region, via a permanently inserted PEG tube, by using an ambulatory pump.
Parkinsons disease (PD) is the second most common neurodegenerative disorder after Alzheimers disease. PD typically develops between the ages of 55 and 65 years and occurs in 1-2% of people over the age of 60 years, rising to 3.5% at age 85-89 years. About 0.3% of the general population is affected, and the prevalence is higher among men than women, with a ratio of 1.5 to 1 [1].
Advanced Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia
Enteral
Oral

Further information

Yes
Topic has been prioritised

Trial or other data

Jul 15PI study (NCT02448914) completes [2].
May 15PI trial to evaluate the continuous addition of entacapone to infused levodopa and carbidopa on the pharmacokinetic (PK) profile in patients with advanced Parkinsons disease (PD) starts (NCT02448914). All patients will receive both study drugs in randomised order each for a day. Either TRIGEL intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone) or Duodopa intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate). Both TRIGEL and Duodopa treatment consists of 3 individually adjusted and pre-defined doses: a morning dose, a continuous 14 h infusion, and extra bolus doses (if required). All TRIGEL doses correspond to 80% of the pre-study individually optimised doses of Duodopa. All Duodopa doses correspond to 100% of the pre-study individually optimized doses of Duodopa. Administration is done through duodenal or upper jejunal infusion via the patient´s permanently inserted gastrojejunostomy tube by means of an ambulatory infusion pump. 11 adults will be recruited in Sweden. Primary outcome is Dose Adjusted Area Under the Curve (AUC) (0-14h) for Levodopa during 14 h infusion on 2 consecutive days; collection of these data is due to complete Jul 15 [2].