Risedronate

Risedronic acid

Clinical data
AHFS/Drugs.com	International Drug Names
Pregnancy category	AU: B3 US: C (Risk not ruled out)
Routes of administration	Oral
ATC code	M05BA07 (WHO)
Legal status
Legal status	UK: POM (Prescription only) US: ℞-only
Pharmacokinetic data
Bioavailability	0.63%
Protein binding	~24%
Metabolism	None
Biological half-life	1.5 h
Excretion	Renal and fecal
Identifiers
IUPAC name (1-hydroxy-1-phosphono-2-pyridin-3-yl-ethyl)phosphonic acid
CAS Number	105462-24-6 Y
PubChem CID	5245
IUPHAR/BPS	3176
DrugBank	DB00884 N
ChemSpider	5055 N
UNII	KM2Z91756Z
ChEMBL	CHEMBL923 N
ECHA InfoCard	100.116.436
Chemical and physical data
Formula	C7H11NO7P2
Molar mass	283.112 g/mol
3D model (Jmol)	Interactive image
SMILES OC(Cc1cccnc1)(P(=O)(O)O)P(=O)(O)O
InChI InChI=1S/C7H11NO7P2/c9-7(16(10,11)12,17(13,14)15)4-6-2-1-3-8-5-6/h1-3,5,9H,4H2,(H2,10,11,12)(H2,13,14,15) N Key:IIDJRNMFWXDHID-UHFFFAOYSA-N N
NY (what is this?)

Risedronic acid (INN) often used as its sodium salt risedronate sodium (USAN) is a bisphosphonate used to strengthen bone, treat or prevent osteoporosis, and treat Paget's disease of bone. It is produced and marketed by Warner Chilcott, Sanofi-Aventis, and in Japan by Takeda under the trade names Actonel, Atelvia, and Benet. It is also available in a preparation that includes a calcium carbonate supplement, as Actonel with Calcium.

Risedronate is taken orally, usually weekly or monthly. Notably, if risedronate lodges in the esophagus, it can lead to esophageal ulcers. Therefore, it is recommended that risedronate be taken with the body upright, and followed by a glass of water. Moreover, risedronate is poorly absorbed when taken with food, so it is recommended that no food or drink other than water be taken for 2 hours before and 30 minutes after taking risedronate. Risedronate has a faster esophageal transit time and different chemical chain which results in less gastrointestinal side-effects than other drugs in this class. The dosage instructions also show that risedronate can be taken with less water than other drugs in the class. Risedronate is also available as a 75 mg tablet to be taken on two consecutive days each month (2CDM) in order to optimize patient adherence. This formulation has been studied in a randomized, double-blind, parallel-group, multinational trial in 1229 postmenopausal women with osteoporosis.

In January 2006 P&G and its marketing partner Sanofi-Aventis filed a Lanham Act false claims lawsuit against rival drugmakers Roche and GlaxoSmithKline claiming false advertising about Boniva. The manufacturers of Boniva, a rival bisphosphonate, were accused in the suit of causing a "serious public health risk" through misrepresentation of scientific findings. In a ruling on September 7, 2006 U.S. District Judge Paul A. Crotty rejected P&G's attempted injunction. P&G was criticized for attempting to "preserve its market share by denigrating Boniva". Judge Crotty wrote that "Roche was clearly entitled to respond with its own data, provided that the data was truthfully and accurately presented".