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Find Data about New Drugs in Development by Therapeutic Class?
TOPIC: R&D databases summarize information about forthcoming products and provide additional drug nomenclature for follow-up in medical bibliographic files. In Pharmaprojects (File 128)*, you can use the therapeutic class to find a category of drugs and then narrow the search to a clinical trial phase worldwide, if desired. In this example, you want to find antiarthritic drugs in Phase III clinical trials in the U.S. in 2006.
You will use the therapeutic class codes for antiarthritic drugs. File 128 uses an adaptation of a therapeutic classification scheme developed by the European Pharmaceutical Market Research Association. To see a list of the codes use HELP CODE 128.
*(Subscriber access.)
COMMAND SUMMARY
BEGIN 128
SELECT TC=M2
SELECT S1 AND USA(S)phase()III
SELECT S1 AND S2
SELECT S3/2006
TYPE S4/6/1-5
TYPE S4/9/1
HOW TO...

1. BEGIN File 128, which contains data on drugs in clinical trials worldwide.
2. SELECT the therapeutic class code for antiarthritic drugs (M2). Note: No truncation is needed because Pharmaprojects automatically selects narrower classes.
3. SELECT the status for USA and clinical trials Phase III. Use the (S) connector so they are in the same field.
4. Combine sets and narrow to the current year. |

?b 128
File 128:PHARMAPROJECTS 1980-2006/Aug W1
(c) 2006 Informa UK Ltd
Set Items Description
--- ----- -----------
?S TC=M2
S1 1276 TC=M2
?S USA(S)PHASE()III
23275 USA
12736 PHASE
3970 III
S2 921 USA(S)PHASE()III
?S S1 AND S2
1276 S1
921 S2
S3 39 S1 AND S2
?S S3/2006
39 S3
9139 PY=2006
S4 22 S3/2006 |

4. TYPE a few records using Format 6 to see the drug names.
Note that Full format in this database is Format 19 and includes the chemical structure.
|

?T S4/6/1-5
4/6/1
0035834
DRUG NAME: golimumab
REVISED: 20060203
4/6/2
0031964
DRUG NAME: GW-406381
REVISED: 20060811
4/6/3
0030418 ** Image available **
DRUG NAME: lumiracoxib
REVISED: 20060721
4/6/4
0030375
DRUG NAME: facilitating cell tech, Chimer
REVISED: 20060407
4/6/5
0030307
DRUG NAME: calcitonin, oral, Emisphere
REVISED: 20060728
|

5. The complete record contains a great amount of detail including the drug name, synonyms and company names. |
?T S4/9/1
4/9/3
DIALOG(R)File 128:PHARMAPROJECTS
(c) 2006 Informa UK Ltd. All rts. reserv.
0030418 ** Image available **
DRUG NAME: lumiracoxib
ORIGINATOR: Novartis (Switzerland) [Launched]
SYNONYMS: COX-189
Prexige
CAS REG NO: 220991-20-8
ROTATABLE BONDS: 5
MOL FORMULA: C15H13CLFNO2
HYDROGEN BOND ACCEPTORS: 4
HYDROGEN BOND DONORS: 2
ALOGP: 4.05
MOL WEIGHT: 293.73
CHEM NAME: Benzeneacetic acid, 2-((2-chloro-6-fluorophenyl)
amino)-5-methy
l- (CAS)
TEXT: Lumiracoxib (Prexige; COX-189) is an orally-active
cyclooxygenase-2 (COX-2) inhibitor, developed by Novartis for the
treatment of pain, osteoarthritis (OA), dysmenorrhoea and
rheumatoid arthritis (RA)
(Press release, Novartis, 21 May 2002).
Marketing
It is launched in 13 countries (as of Jul 2006),
including Brazil, the UK (2005), Australia, Mexico and New
Zealand (2006) for OA (100mg/day), acute pain and primary
dysmenorrhoea (400mg/day) (Company presentation, Novartis, 20
Sep 2005; MIMS UK, Jan 2006; Press release, Novartis, 24 Apr
2006). It is approved in 22 countries (as of Sep 2005), . . . |
| Details of the Phase III clinical trials |
Clinical
Phase III
It is in a US Phase III trial in 1200 primary
hip OA patients, to support a US approval resubmission. The
trial will compare lumiracoxib 100mg with celecoxib 200mg and
placebo (Company presentation, Novartis, 20 Sep 2005). In a
1yr multinational, stratified, randomized, double-blind,
double-dummy, active- controlled, parallel-group Phase III
trial (TARGET) in >18325 OA patients aged >50yr, lumiracoxib
400mg once-daily reduced the incidence of upper GI ulcer
complications by 83% cf naproxen (qv) and 76% cf ibuprofen
(79% overall) in patients not on low-dose ASA. In patients on
ASA, lumiracoxib caused a 21% decrease cf the NSAIDs, with a
66% decrease for the total population. There was no
increased cardiovascular risk (MI
incidence, congestive heart failure or other thrombotic
events) cf the 2 NSAIDs (Press releases, Novartis, 21 May
2002 & 20 Aug 2004). In a 13wk Phase III study in 1042 OA
patients, lumiracoxib 200-400mg once-daily significantly
lowered gastroduodenal ulcer rate cf ibuprofen 800mg tid,
and gave a gastroduodenal ulcer rate similar to celecoxib
200mg once-daily (Digestive Dis Wk (San Francisco),
2002, Abs M1732). A Phase III long-term GI safety outcome
study in >14000 patients has been conducted. This
included trials in multiple pain indications with
once-daily dosing. In 2 trials (300-400 patients each) in
OA and RA, lumiracoxib 400mg/day was comparable to
diclofenac after 4wk in reducing pain and stiffness. In a
13wk Phase III trial, lumiracoxib was significantly more
effective at controlling pain in arthritis of the knee
cf celecoxib at 2, 4 and 8wk of treatment
(Pharmaceutical Marketing, 2002, 14, 22). . . . . |
| Status of the drug in countries around the world |
STATUS: (Active)
World Launched
Argentina Registered
Australia Launched 2006
Brazil Launched 2005
Mexico Launched 2006
New Zealand Launched 2006
UK Launched 2005
USA Phase III Clinical Trial
|
Note the therapeutic class M2z for antiarthritic drugs.
In this example, we typed out only one record. To see all drugs in Phase III, you would type all records in S2. |
THER. CLASS: N2B (Analgesic, NSAID)
M2Z (Antiarthritic, other)
G3A (Menstruation disorders)
S1Z (Ophthalmological)
ORIGIN: CH-SY (Chemical, synthetic)
RTE OF ADMIN:A-PO (Alimentary, po)
INDICATIONS: Pain, general L Launched
Arthritis, osteo L Launched
Dysmenorrhoea L Launched
Arthritis, rheumatoid C3 Phase III Clinical Trial
PHARM. CODE: OX-C-2-AN Cyclooxygenase 2 inhibitor Enzyme,
Oxidoreductase, Cyclooxygenase 2 inhibitor COX-2 inhibitor
E-OR-OX-C-2-AN
TARGET DATA CODE: 5743: PTGS2; 5743: COX2; 5743: COX-2;
5743: PHS-2; 5743: PGG/HS; 5743: PGHS-2; 5743:
cyclooxygenase-2; 5743: prostaglandin G/H synthase and
cyclooxygenase 2 |
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