A	B	C	D
1	Main
2		Brand Name	Invega
3		Generic Name	paliperidone ER OROS
4		Mechanism	Uses OROS - releases drug into bloodstream over 24-hour period
5			Similar to risperidone - only differentiated by one hydroxy group - raises IP issues??? - the active metabolite?. Not extensively metabolized by the liver and is excreted largely unchanged through the kidney.
6		Approved	12/19/2006
7		Administration	Oral
8		Indication	Schizophrenia, bipolar mania, schizoaffective disorder.
9		IP	October 2009. JNJ expects 5 years of Hatch-Waxman exclusivity. 12/19/2011. Injectable in development.
10		Side Effects	"Less than Risperdal". QTC on the label?
11		Timeline	Submitted NDA 11/30/2005; PDUFA 9/30/2005; approvable (did not specify new data); filed MAA in May 2006.
12		Regulatory	Filed in EU in May 2006.
13		Price	9.14 for 3mg/6mg, 13.71 for 9mg.
14		Clinical Studies	>1600 patients
15
16			22% recurrence events vs 52% for placebo. Trial halted early for efficacy
17
18			Paliperidone vs placebo vs olanzapine - March 2004 start n=595
19
20			12/14/2005 press release notes Paliperidone ER presented at scientific meeting.
21				discontinuation rates similar to placebo - better than risperdal?
22				not extensively metabolized by the liver
23				steady release over 24 hour period
24				AE include akathisia, EPS, tachycardia, sinus tachycardia
25
26			5/23/2006 one study showed 4% discontinuation for placebo, 2% for 3mg, 5% for 9mg and 3% for 15mg.
27		Rx
28			10/31/2008
29			10/24/2008
30			10/17/2008	16261
31			10/10/2008	16949
32			10/3/2008	17268
33			9/26/2008	15908
34			9/19/2008	16074
35			9/12/2008	16601
36			9/5/2008	16012
37			8/29/2008	16168
38			8/22/2008	15909
39			8/15/2008	16465