Volume: 05

Drug Information Centre (DIC) Indian Pharmaceutical Association, Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Drug Information Bulletin (Electronic)

th

Year

Number: 35

10thDecember 2011

Draft rules for Compensation in case injury or death during the Clinical Trial published by Govt. of India NEW DRUG: Nomegestrol/oestradiol FDA approves Oxybutynin for overactive bladder CDC issues new latent TB treatment guidelines Four medications linked to most emergency hospitalizations for older Americans Fierce Biotechs 2011 women in biotech Situation Vacant Forthcoming Event

Content

Draft rules for Compensation in case injury or death during the Clinical Trial published by Govt. of India

Details are available at http://www.cdsco.nic.in/html/compensation_during_clinicaltrial.pdf NEW DRUG: Nomegestrol/oestradiol Zoely (Merck Sharp and Dohme) 24 white active tablets and 4 yellow placebo tablets Approved indication: contraception

2 This new oral contraceptive contains the progestogen nomegestrol (2.5 mg) combined with the endogenous oestrogen 17-oestradiol (1.5 mg). Nomegestrol is similar to endogenous progesterone and has a strong affinity for the human progesterone receptor. It also has strong anti-gonadotropic activity and moderate antiandrogenic activity. The contraceptive efficacy of this new combination has been compared to drospirenone 3 mg/ethinyloestradiol 30 microgram (21 active and 7 placebo tablets) for 13 menstrual cycles in women aged 1850 years.1 In this open-label trial, there were 4 pregnancies in the 1587 women who took the nomegestrol combination pill and 3 pregnancies in the 534 women who took the comparator pill (estimated Pearl Index in women aged 35 years = 0.38 vs 0.81). Most pregnancies were thought to be related to missed pills or conditions that affect contraceptive efficacy, such as diarrhoea or vomiting. However the reason for contraceptive failure was not identified for one pregnancy in the nomegestrol/oestradiol group. There were no pregnancies in women aged 36 and over. The incidence of breakthrough bleeding or spotting in the trial was slightly higher with the nomegestrol combination pill than with the comparator during most cycles (1420% vs 1117%). However, this decreased over time in both groups. Periods were shorter and lighter with nomegestrol/oestradiol and missed periods were more common. This may have been because there were only four placebo pills with nomegestrol/oestradiol compared to seven with the comparator. One-third of women had acne at baseline. By cycle 13, this had decreased to 24% in the nomegestrol/oestradiol group and 16% in the comparator group.1 The contraindications and precautions for nomegestrol/ oestradiol are similar to other combined pills, as are the adverse effects. Acne (15.3% vs 7.1%), irregular withdrawal bleeding (11.7% vs 0.4%), weight gain (7.9% vs 6.2%) and headache (6.6% vs 6.2%) were more common with nomegestrol/oestradiol than with drospirenone/ethinyloestradiol. These events led to discontinuation in some women. There were three serious adverse events possibly related to treatment. These were menorrhagia in the nomegestrol/oestradiol group, and deep vein thrombosis and systemic lupus erythematosus in the comparator group.1 The combination of nomegestrol and oestradiol proved to be an effective contraceptive compared with drospirenone/ ethinyloestradiol. It is unclear if it will have any advantages over currently approved contraceptive pills, however periods may be shorter and lighter. Reference: 1. Mansour D, Verhoeven C, Sommer W, Weisberg E, Taneepanichskul S, Melis GB, et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinyloestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care 2011 Oct 13.
Source: Aust Prescr 2011; 34:194

FDA approves Oxybutynin overactive bladder

for

Med Page Today reports, "The FDA has approved a topical gel formulation of oxybutynin 3% for the treatment of overactive bladder with symptoms of

urinary incontinence, urgency, and frequency." Oxybutynin "is applied once daily, in 84 mg doses, to the thigh, abdomen, upper arm, or shoulder through a metered-dose pump." Adverse reactions "included dry mouth, application-site erythema, and application-site rash."

prevent latent TB infection progressing to active TB disease." The AFP reports, "The CDC recommended the shorter combination treatment for people over 12 who have been recently exposed to TB, have tested positive for infection or show evidence of healed pulmonary TB after a radiological scan," including "HIV-infected patients who are otherwise healthy and are not taking antiretroviral medications." Four medications linked to most emergency hospitalizations for older Americans The New York Times "Well" blog reported, "Blood thinners and diabetes drugs cause most emergency hospital visits for drug reactions among people over 65 in the United States," according to a study published in The New England Journal of Medicine. Researchers found that "just four medications or medication groups - used alone or together - were responsible for two-thirds of emergency hospitalizations among older Americans." The investigators looked at data from 58"hospitals...participating in a surveillance project run by the C.D.C. that looks at adverse drug events." The National Journal reported that the researchers found that "forty-six percent of hospitalizations involved medicines used to prevent blood clots; a single anticoagulant, warfarin, was responsible for one-third of hospitalizations, the report found. Another 25 percent involved diabetes medications, either insulin injections or medicines taken by mouth." WebMD reported, "The researchers estimated that 265,802 visits to emergency departments for adverse drug events occurred from 2007 to 2009 for adults 65 or older." More than "a third of these visits, or nearly 100,000, required hospitalization." The investigators found that "unintentional overdose of medication was the most common

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Mr. P. D. Sheth- Vice President, FIP delivering a lecture in a recent workshop entitled "WHO-GMP Aspects and Global Regulatory Affairs-Series III" organized by IPA, Delhi Branch

CDC issues new latent TB treatment guidelines Health Day reports that "new guidelines on treating so-called 'latent' tuberculosis infection in the United States should significantly shorten and simplify the course of the therapy from about 9 months to 3 months, according to the US Centers for Disease Control and Prevention." The new regimen changes the treatment from "270 daily doses of the anti-TB drug isoniazid" to "12 onceper-week doses of isoniazid, along with another anti-TB drug called rifapentine." The guidelines are published in the CDC's Morbidity and Mortality Weekly Report. CDC Director Dr. Thomas Frieden said in a news release that "This regimen" is a "potential...game-changer" as it provides "a new, effective option that will reduce by two-thirds -- from nine months to three months -- the length of time someone needs to take medicine to

reason, accounting for nearly two-thirds of hospitalizations." Fierce Biotechs 2011 women in biotech Female biotech executives have been key players in many of the biggest events in the industry this year--Takeda Pharmaceutical's buyout of Nycomed, the merger of Alkermes ($ALKS) and Elan Drug Technologies and the sale of Plexxikon to Daiichi Sankyo. Should we be surprised? No, women in this industry defy the odds when they rise to key positions in the male-dominated biotech game. Of course we're seeing them accomplish big things. But they deserve recognition. So, we're excited to bring our readers Fierce Biotechs much-awaited-and belated-Women in Biotech feature. We had an overwhelming response to our call for nominations this year, with more than 130 great submissions and an amazing slate of candidates. True to our mission of providing readers the top news in biotech, many of the honorees here are women who drove some of the big stories we covered this year. We also wanted the women featured this year to represent the best of the global biotech industry, and you'll find women here who are making an impact for organizations based in Asia, Europe and here in the U.S. These women are inspiring, not just to women, but (at least speaking for the males on our team) men involved in the industry, too. Our profiles will bring you up to date with what each of these female movers in biotech are working on these days. Some are rallying scientists at young startups, gearing up for important late-stage trials or leading research of serious health concerns such as HIV. For each of the honorees, there are unique stories about how impressive women

4 have gotten ahead in the competitive biotech field. "I think that the potential interesting little extra that you get from speaking to some of the women in biotech is we've probably been challenged with thinking a little bit more about how to cultivate our careers," said Abbie Celniker, chief executive of Eleven Biotherapeutics and one of this year's Women in Biotech. "As a result, we can be a tiny bit more selfreflective because we've had to do lots of course correction to make sure we could compete in the days when it was more predominately male." Situation Vacant Approved QC Chemist require urgently for a reputed company at Kolkata. Interested persons are advised to send application with CV atipabengalbranchn@gmail.com Forthcoming Event

63rd Indian Pharmaceutical Congress

16-18 December 2011 Organized by: Indian Pharmaceutical Congress Association Hosted by: Indian Pharmaceutical Association Venue: Bangalore International Exhibition Centre 10th Mile, Tumkur road Bengaluru - 562 123 Secretariat Office / Mailing Address: No. 2, Ravi Kiran Apartment 12, Plain Street, Infantry Road Cross, Shivaji Nagar, Bengaluru - 560001 Ph. : +91-80-4202 5385, 4202 5386 E-mail : info@ipc-2011.com