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Remeron Smelt (rapidly disintegrating tablets)


Conclusion

Remeron Smelt is a new rapidly disintegrating formulation of the antidepressant mirtazapine (Remeron). Remeron Smelt tablets are bioequivalent to conventional Remeron tablets, so efficacy, uptake and elimination can be assumed to be the same, provided that the rapidly disintegrating tablets are administered without water. Remeron Smelt tablets are slightly less expensive than conventional tablets. The new formulation may benefit the few patients that have difficulty swallowing a tablet. Other than that, the new formulation does not add anything new.

 

Background

Remeron Smelt was first marketed on 13 May 2002 in the strengths 15 mg, 30 mg and 45 mg.

 

A Remeron Smelt tablet is placed on the tongue, where it dissolves and forms a microsuspension that moves slowly down through the oesophagus. Remeron Smelt tablets are dosed the same as conventional Remeron tablets, i.e. 15-45 mg/day. The Cmax would presumably be higher if the rapidly disintegrating tablets were taken with water, but there are no studies that describe the efficacy of this method of administration.

 

Efficacy

The efficacy data on Remeron Smelt stems from a bioequivalence study whose results show that a Remeron 30 mg rapidly disintegrating tablet and a Remeron 30 mg conventional tablet are pharmacokinetically identical (with respect to AUC and Cmax) if the rapidly disintegrating tablet is taken without water. Dose proportionality enables extrapolation of the pharmacokinetic data obtained for the 30 mg rapidly disintegrating tablets to the 15 mg and 45 mg rapidly disintegrating tablets.

 

Remeron Smelt is included under the general reimbursement scheme.

 

Price examples

 

Product Cost (in DKK) per DDD
Remeron Smelt 15 mg 6.61
Remeron tablets 30 mg 13.04
Remeron Smelt 30 mg 12.13
Remeron tablets 45 mg 18.49
Remeron Smelt 45 mg 17.94

 

 

Additional information is available from the summary of product characteristics published by the Danish Medicines Agency (Danish only).
Last modified: May 13th 2002


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