Summary
- Lurasidone is an atypical antipsychotic owned by Dainippon Sumitomo Pharma.
- Phase 3 PEARL 1 Study: 6-week, multi-site, double-blind placebo-controlled trial in 500 pts with DSM4 schizophrenia with PANSS score greater than 80.
- RESULTS: 80mg dose was superior to placebo; 40mg & 120mg was not.
- MAIN side effects: akathisia, somnolence, Parkinsonism, weight gain.
- Similar to Abilify market (AstraZeneca).
- Economic factors which reduce the potential market are discussed.
Analysis
So far, Lurasidone worth keeping an eye on, given its limited metabolic and weight side effects. While mean weight gain was low (0.3kg), 5.1% had significant weight gain (probably defined as greater than 7% of body weight) vs placebo (2.4%). Glucose & lipid changes were similar to placebo.
Because some of the largest purchasers of these expensive branded atypical antipsychotic agents are state Medicaid programs, changes in their buying habits would have a large effect on sales. Most state Medicaid programs are cutting back on their budgets. Since atypicals, such as Zyprexa (Lilly ), Abilify (Otsuka, Bristol Myers Squibb), Risperdal & Invega (Ortho-McNeil-Janssen; OMJPI), and Seroquel (AstraZeneca ), are often the largest line item cost in their pharmacy budgets, many states are currently in the process of reducing access to these drugs. The recent availability of generic risperidone (Teva Pharmaceuticals, Mylan Inc) is contributing to this, as well. These factors reduce the potential market for Lurasidone, which would be the 8th product in this category (9th if you include clozapine).
More on Lurasidone:
Akathisia is high (18% vs 3%), which is very similar to Abilify. Somnolence is not too bad (12% vs 6%). Nausea was 15% vs 6%. QTc interval changes on the ECG were said to be low.
End-points used were change in PANSS score from baseline vs placebo and change in CGI-S score from baseline.
Resources:
This author consults with leading institutions through GLG
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.


