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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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Stock #: 54309; Last modified: 14 Sep 2011



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