Night time release pill gains EU approval

By Nick Taylor

- Last updated on GMT

Related tags Active ingredient Pharmacology

Nitec has received approval in Europe for its rheumatoid arthritis treatment Lodotra making it the first product using SkyePharma’s propriety drug delivery technology Geoclock to come to market.

The Geoclock technology ensures that the active ingredient, prednisone, is released four hours after the tablet has been ingested. Consequently if a patient took a tablet prior to going to sleep at 10pm prednisone release would start at 2am and reach maximum plasma levels at 4am.

Owing to the change in rheumatoid arthritis patients’ circadian rhythms, details of which can be found here​, research suggests this is the optimum time to maximise plasma levels to prevent pain and stiffness upon waking.

The optimum time is hit as Geoclock encases the active ingredient in an outer tablet layer consisting of a mixture of hydrophobic wax and brittle material. This layer is not degraded by the changes in pH in the digestive system and releases the drug after a set period of time.

Nitec looks to take it global

Nitec gained approval for Lodotra in Germany, which looks set to be the first market the product enters. This is predicted to occur in the first half of 2009, with Marketing Authorisations also being sought in the other 15 countries the product is approved in under the European Medicine Agency’s (EMEA’s) Decentralised Procedure.

SkyePharma will receive a mid single digit percentage royalty on net sales and will manufacture the product from its facility in Lyon, France. The news caused a spike in SkyePharma’s share price, rising from 140p at close yesterday to 167p earlier today.

Lodotra is currently in another Phase III trial in preparation for the filing of a New Drug Application (NDA) in the US.

Related topics Ingredients Delivery technologies

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