The COX-2 inhibitor rofecoxib appears to be associated with side effects including blood pressure destabilization in users with rheumatoid or osteoarthritis, researchers report. The researchers found that patients taking rofecoxib were more likely to develop edema or to have an increase in blood pressure than patients using celecoxib or other NSAIDs." Dr. Wolfe of the Arthritis Research Center Foundation in Wichita, Kansas, and colleagues came to this conclusion after examining data on 8538 patients taking part in an ongoing study. In particular, in rofecoxib compared to celecoxib users, there was a significant increase. Among patients reporting hypertension, users of rofecoxib had a significantly increased risk of greater blood pressure compared to nonusers (odds ratio, 1.55). This was not true of users of celecoxib or non-selective NSAIDs. Nevertheless, despite these particular findings, Dr. Wolfe stressed that "patients taking any NSAID should be observed for increases in blood pressure or development of edema."
Generic Drugs And US Market
Generics have become an integral part of the growth machine of the pharmaceutical industry. During 2003, generics growth reached 24 per cent - compared with growth of 'brands' of just 8 per cent. In 2003, generics accounted for 30 per cent or greater of drug volumes dispensed in several major markets, including the USA, Canada, the UK and Germany. Of the top 10 fastest growing corporations in 2003, six were generic companies, including in first place Schwarz Pharma, followed by Endo, Apotex, Hexal, Ranbaxy and Pliva. Looking at 20 drugs launched mainly since 2000, including Cialis (tadalafil), Levitra (vardenafil), Zetia (ezetimibe), Spiriva (tiotropium bromide) and Pegasys (peginterferon alpha-2a), Lewis of IMS Health estimated that if this cluster of drugs had been launched in the major five European markets in the same year, they would have made an extra $500-700 million in revenues. 6,525 active products were in development as of March 2004. IMS has forecasted 30-32 launches worldwide of new active substances (NASs) in 2004. In 2003, the average time to market for an NAS was 13 years and 3 months, five months longer than in 2002 - and three products took up to 25 years. Improving the efficiency of drug development is one of the biggest challenges facing not only respective drug companies, but the FDA
The US FDA is advocating its 'Quality for the 21st Century Initiative', aimed at a reform of its manufacturing regulations, designed to make manufacturing safer and more efficient, while simultaneously lowering costs. The FDA is also working very hard under the direction of Congress to improve the efficiency and speed of the generic drug programme, with the aim of reducing the 'back-and-forth' between companies and the FDA and improving overall review times. Among other initiatives planned are 'proof of concept' trials for candidate screening, or essentially, encouraging companies to perform quicker and less expensive trials that could serve as a sensitive indicator of a drug's potential for success
List of first time generics approved by USFDA in June 2004.
1. Ciprofloxacin tablets, usp 250 mg/500 mg/750 mg, (manufacturers: Eon Labs, Mylan, Carlsbad, Sandoz, Cobalt, Barr, Hikma, Dr. Reddy's, Ranbaxy, Martec Scientific, Ivax, Genpharm, Teva )
2. Ciprofloxacin ophthalmic solution, usp 0.3% (manufacturer: Novex Pharma, Bausch & Lomb),
3. Adenosine injection, usp 3 mg/ml; packaged in 6 mg/2 ml, and 12 mg/4 ml single-dose vials (manufacturer: Sicor Bedford, Baxter)
4. Adenosine injection, usp 3 mg/ml; packaged in 6 mg/2 ml single-dose syringes (manufacturer: Baxter),
5. Levothyroxine sodium tablets, usp 0.025 mg/ 0.05 mg/ 0.075 mg/ 0.088 mg/ 0.1 mg/ 0.112 mg/ 0.125 mg/ 0.15 mg/ 0.175 mg/ 0.2 mg/ 0.3 mg
6. Clarithromycin extended-release tablets 500 mg (manufacturer: Andrx)
7. Albuterol/Salbutamol Sulfate inhalation solution 0.042% base, (manufacturer: Nephron)
8. Oxycodone hydrochloride tablets, usp 15 mg and 30 mg (manufacturer: Mallinckrodt)
Drug May Offer Aphrodisiac For Women
A drug that seems to drive female rats mad for sex may offer the first real scientific aphrodisiac for women. The drug PT-141, is being developed for use to fight impotence in men, but the researchers said tests showed it also aroused female rats. The female rats flirted more when injected with the drug the scientists said. Although the sexual behavior of rats is different from that of humans, the effects of pharmacological manipulations of appetitive and consummatory sexual behaviors are similar in male rates and men," the researchers wrote. The same is probably true of women, they added. Although the drug was injected into the rats, in human tests for impotence it takes the form of a nasal spray. PT-141 is the first of a new class of drugs called melanocortin agonists being developed to treat sexual dysfunction. It may be safer than current impotence drugs because it does not affect the blood vessels. Current drugs increase blood flow and could be dangerous to people on some heart medications.
Ezetimibe Plus Simvastatin Helps To Reach LDL Cholesterol Goal
Combining a drug that inhibits cholesterol absorption with one that blocks cholesterol synthesis may help patients achieve an LDL cholesterol level of < 100 mg/dL, according to a report published in the June 15th issue of The American Journal of Cardiology. The findings are based on a study of 710 patients with LDL cholesterol levels of 130 mg/dL or higher who were randomized to receive Simvastatin (20 mg) alone or one of three Simvastatin doses combined with Ezetimibe (Zetia of Merck) (10 mg) for 23 weeks. In all of the groups, Simvastatin doses were doubled up to a maximum of 80 mg/day to achieve adequate cholesterol levels. All three combination regimens produced greater LDL cholesterol reductions than Simvastatin Monotherapy. Treatment with these drugs together "allowed more patients to reach LDL cholesterol < 100 mg/dL at a lower Simvastatin dose and with fewer dose Titrations than Simvastatin Monotherapy. Based on these encouraging findings, an Ezetimibe/Simvastatin combination drug is currently under development.
Switzerland: Biotech Patents Come Under Fire
The pharmaceutical industry and non-governmental organisations have voiced strong reservations about a controversial law on the patenting of genes. The government says the new legislation, which is currently under consultation in Switzerland, would help safeguard the country's booming biotech sector. The proposal forms part of an overall revision of Swiss patent law. It was originally put forward in 2002 but was poorly received by the public. A second consultation period began last month and is due to run until the end of October. The government says the proposed law would protect biotechnology in Switzerland and encourage more investment in research and development. Switzerland has a strong biotechnology sector: since 1998 the country, which is home to 227 biotech companies, has been ranked number six in Europe and number nine in the world.
US Patent For Method For Coating Pharmaceutical Dosage Forms
Cappola; Michael L. of Boehringer Ingelheim Pharmaceuticals were awarded a US Patent on 22nd June 2004 for a method for coating pharmaceutical dosage List of forms. 6+The invention provides a process for coating a branded pharmaceutical dosage form for the purpose of covering any embossed or printed matter or any colored coating by the application of an amount of coating which is sufficient to obscure any identifying indicia without compromising the stability or releasability of the drug that is contained in the dosage form. The invention also provides a method of coating a micro tablet to form a rounded tablet In addition, there is disclosed a method of incorporating additional active ingredients into a micro tablet.
Adult Stem Cells Transfer Improves Heart Function
Adult stem cells taken from bone marrow can improve heart function in patients who have suffered a heart attack, German researchers said. Stem cells are master cells that can develop into specialized cells. They hold the promise of treating a range of illnesses such as Alzheimer's, diabetes and heart disease. But their use is controversial because the most promising stem cells are derived from human embryos. Dr Helmut Drexler, of the Medical University of Hannover in Germany, used adult stem cells from bone marrow of heart-attack patients to see if they could improve heart function. "Our results lend support to the concept that bone-marrow cells can be used to enhance functional recovery in patients," he said in a report in The Lancet medical journal. Drexler and his team randomly selected 60 patients who had had treatment following a heart attack to receive either an injection of the stem cells into the artery supplying the damaged area of the heart or standard therapy. Six months later, the stem cell transfer patients had about a 7 per cent improvement in function of the heart, compared to 0.7 per cent in the other group.
Compiled from WWW by Venkat Appaji Padmanabhuni appajipv@hotmail.com