5/6/2008 3:31:11 PM Biopharmaceutical company Vanda Pharmaceuticals, Inc. (VNDA) said on Tuesday that data from the 4-week Phase III trial and a pooled analysis of three long-term 52-week trials showed that iloperidone proved to safe and efficient. Iloperidone is a 5HT2/D2 antagonist antipsychotic currently under review by the FDA for the treatment of schizophrenia.
In the 4-week short-term Phase III trial iloperidone proved to be more effective than placebo in the short-term treatment of acutely exacerbated schizophrenia, providing relief across both positive and negative symptom domains. Iloperidone showed significantly greater improvement than placebo in PANSS-T scores.
Data presented from a 4-week Phase III trial also demonstrated that rates of worsened BAS (6) total score was similar between iloperidone and placebo but significantly higher with ziprasidone versus placebo. Iloperidone also showed significant improvements versus placebo on six ESRS (7) subscales.
Results from the 52-week Phase III trial, comparing a dose range of iloperidone to haloperidol, demonstrated that iloperidone showed significant improvements in extrapyramidal symptoms, or EPS, at endpoint, as measured by ESRS, versus haloperidol and a significantly lower percentage of patients on iloperidone experienced worsening EPS and akathisia.
Further, Pharmacogenetic analysis in a Phase III trial studying the efficacy of iloperidone in acute schizophrenia identified six single nucleotide polymorphisms associated with efficacy of iloperidone.
Vanda Pharma said that the data presented are part of the New Drug Application, or NDA, submitted and currently under review by the FDA and demonstrate that iloperidone is effective in the short-term treatment of schizophrenia and that iloperidone is non-inferior to haloperidol in long-term maintenance measured as time to relapse over 52 weeks.
Chief Medical Officer of Vanda Pharma, Paolo Baroldi stated, “Pharmacogenetics research to help identify markers of schizophrenia treatment response is fundamental and may help usher us into an era of personalized treatments in schizophrenia and bring us one step closer to providing the optimal treatment for each patient.”
VNDA is currently trading at $5.66, up 19 cents or 3.47% on a volume of 3.44 million shares.
In the 4-week short-term Phase III trial iloperidone proved to be more effective than placebo in the short-term treatment of acutely exacerbated schizophrenia, providing relief across both positive and negative symptom domains. Iloperidone showed significantly greater improvement than placebo in PANSS-T scores.
Data presented from a 4-week Phase III trial also demonstrated that rates of worsened BAS (6) total score was similar between iloperidone and placebo but significantly higher with ziprasidone versus placebo. Iloperidone also showed significant improvements versus placebo on six ESRS (7) subscales.
Results from the 52-week Phase III trial, comparing a dose range of iloperidone to haloperidol, demonstrated that iloperidone showed significant improvements in extrapyramidal symptoms, or EPS, at endpoint, as measured by ESRS, versus haloperidol and a significantly lower percentage of patients on iloperidone experienced worsening EPS and akathisia.
Further, Pharmacogenetic analysis in a Phase III trial studying the efficacy of iloperidone in acute schizophrenia identified six single nucleotide polymorphisms associated with efficacy of iloperidone.
Vanda Pharma said that the data presented are part of the New Drug Application, or NDA, submitted and currently under review by the FDA and demonstrate that iloperidone is effective in the short-term treatment of schizophrenia and that iloperidone is non-inferior to haloperidol in long-term maintenance measured as time to relapse over 52 weeks.
Chief Medical Officer of Vanda Pharma, Paolo Baroldi stated, “Pharmacogenetics research to help identify markers of schizophrenia treatment response is fundamental and may help usher us into an era of personalized treatments in schizophrenia and bring us one step closer to providing the optimal treatment for each patient.”
VNDA is currently trading at $5.66, up 19 cents or 3.47% on a volume of 3.44 million shares.
2008 wird ein hartes Börsenjahr !
Keine Macht der Frick-RSR-TR-PSR-Connection !
Keine Macht der Frick-RSR-TR-PSR-Connection !
