Lundbeck launches bipolar drug Sycrest in the UK
pharmafile | January 17, 2012 | News story | Sales and Marketing |Â Â Lundbeck, Saphris, Sycrest, zyprexaÂ
Lundbeck has launched Sycrest in the UK for the treatment of acute attacks of bipolar I disorder.
Sycrest (asenapine) is now available as a sublingual (quick release) treatment for moderate to severe manic episodes in adults with bipolar I disorder.
The drug is sold by Merck in the US under the brand name Saphris.
Sycrest showed efficacy as early as day two in the reduction of manic symptoms over three weeks in its most recent Phase III trials. The effect was shown to be sustained over 12 weeks in a subsequent double blind extension study.
A head-to-head between Sycrest and top-selling bipolar disorder drug Zyprexa found the new treatment improved depressive symptoms compared with placebo at day seven.
NICE currently recommends that Lilly’s Zyprexa, AstraZeneca’s Seroquel, Janssen’s Risperdal, valproate or lithium should be considered for acute attacks – or as a prophylactic – if symptoms have responded to these drugs before.
One of Sycrest’s key selling points is the lower incidence of serious weight gain in patients compared to drugs such as Zyprexa.
Combined short and long term studies have shown that the mean weight gain with Sycrest was 0.8 kg, and observations from a 12-week study showed the mean weight change to be 1.9 kg vs. 4.1 kg seen in olanzapine patients. Lundbeck add that Sycrest also has a minimal effect on metabolic parameters, such as glucose, lipids and triglycerides, unlike Zyprexa.
Sycrest could fit into this pathway of care as a treatment for manic episodes, but is not licensed to treat longer-term depression associated with the disease as these other drugs are. A NICE appraisal for Sycrest is scheduled later this year.
The launch also coincides with the availability of generic forms of Zyprexa in the UK.
Zyprexa (olanzapine), has been one of the biggest selling drugs in recent years, with the NHS in England spending £113.9 million on the drug in 2010.
But it went off patent in the UK in September, and there are now a number of cheaper generics available.
Sycrest’s cost is £102.60 for a 60-pack, either as a monotherapy or in combination with mood stabilisers lithium or valproate.
Many other atypical antipsychotics are also licenced to treat schizophrenia, but last year the EMA rejected Sycrest for this indication, saying it failed to demonstrate effectiveness.
Ben Adams
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