NALMEFENE DOES WELL IN PHASE III CLINICAL STUDIES FOR THE TREATMENT OF ALCOHOL DEPENDANCE

NALMEFENE DOES WELL IN PHASE III CLINICAL STUDIES FOR THE TREATMENT OF ALCOHOL DEPENDANCE

The last study in its Phase 3 program evaluating nalmefene for the treatment of alcohol dependence has shown the encouraging results. Results from this 718 patient, double-blind, placebo controlled trial were consistent with the profile observed in previous clinical studies of nalmefene.Nalmefene is the first treatment that has been specifically developed to help patients reduce their harmful levels of alcohol consumption, therefore offering patients, physicians and payors a highly differentiated treatment option. Nalmefene builds on a novel principle of treating alcohol dependence. Unlike existing therapies, treatment with nalmefene is not aimed at keeping patients from drinking. Instead, nalmefene helps patients control and limit the intake of alcohol. This is supported by specialists as a valuable treatment option to increase willingness among patients to initiate treatment and to promote compliance. In addition, nalmefene distinguishes itself by being available as a tablet formulation to be taken only according to need, whereas existing pharmaceuticals must be taken continuously over a longer period of time and are aimed at maintaining abstinence.

Lundbeck assessed a wide range of primary and secondary endpoints in its Phase 3 program for nalmefene including: number of heavy drinking days per month, total alcohol consumption, proportion of responders based on drinking measures, alcohol dependence symptoms and clinical status, liver function and other laboratory tests, pharmaco-economic outcomes and treatment discontinuation effects. All assessments were consistently in favour of nalmefene compared to placebo, though some were not statistically significant at every single time point. Overall, nalmefene reduced heavy drinking days and total alcohol consumption by more than 50% compared to pre-treatment baseline. The effect was observed already during the first month of treatment and was maintained throughout the study period in the three trials.Nalmefene is a small molecule opioid receptor antagonist that inhibits the reward pathway in the brain that reinforces the desire and craving for alcohol and other addictive substances. As a result, nalmefene removes a person’s desire to drink.Alcohol dependence is a disease in which the afflicted person continually craves alcohol, is unable to limit his or her drinking, needs to drink greater amounts to get the same effect and has withdrawal symptoms after stopping alcohol use. Alcohol dependence also has potentially fatal consequences such as liver cirrhosis and cancer, among others. As a result, this disease is one of the most serious health concerns in the western world, both socially and economically, with estimated associated costs to society of at least EUR 200 billion per annum. 10% of deaths and 25% of all emergency room admissions in the western world are directly alcohol related. According to the World Health Organization, there are 60 million people inEuropealone who are ‘riskful’ consumers of alcohol, which is categorized as alcohol consumption of 40-60 grams (5-6 standard drinks) by females and 60-100 grams (7-8 standard drinks) by males on a single drinking day. Despite this, alcohol dependence tends to be severely under-diagnosed with only approximately 13% of alcohol dependants receiving treatment, characterizing it as a large unmet medical need.

Currently, conventional methods of treating alcohol dependence require abstinence from drinking as a starting point – a high hurdle for an alcohol dependent patient. There are only a few pharmaceutical compounds that have received marketing approval to help alcohol dependent patients maintain abstinence. All these treatments, including psychosocial counseling measures, cannot prevent patients from relapsing and the long term prognosis remains poor. There are no approved therapies on the market yet to proactively help curb a person’s urge to drink

REFERENCE

1. www.globalpharmasectornews.com

 2. www.nature.com

 3. www.the-alcoholism-guide.org

ASLAM ARGODN

FIRST YEAR M PHARM

AL-SHIFA COLLEGE OF PHARMACY

"DRACO" anti virus drug to cure all disease

DRACO -ANTIVIRUS DRUG TO CURE ALL DISEASES.

A group of researchers at Lincoln Laboratory, Massachusetts Institute of Technology (MIT), Lexington, Massachusetts, United States of America headed by Todd H. Rider published an interesting research article on broad spectrum antiviral therapeutics at PLoS ONE, an online peer-reviewed scientific journal which publishes reports on primary research from any scientific discipline.The article explains a new broad spectrum antiviral approach called Double-stranded RNA Activated Caspase Oligomerizer (DRACO) which cured 15 different viral infections during clinical trials in mice. The viruses tested includes dengue flavivirus, Amapari and Tacaribe arenaviruses, Guama bunyavirus, and H1N1 influenza and the drug was even capable to rescue a mice challenged with H1N1 influenza, popularly know as Swine flu.

In contrast to the antiviral drugs in use nowadays, DRACO adopts a different approach in combating viral infection. It involves a two stage process. When a virus enters a host cell, it tries to multiply itself by multiplying their genetic material. This process produces baby viruses which then infects other cells, spreading the infection. During this process, virus creates a double stranded RNA (dsRNA) which forms the initial target of DRACO. dsRNA is not found in normal, healthy and uninfected cells.The first protein part of DRACO binds to the viral dsRNA.The second part of the drug induces a natural mechanism called apoptosis, which is a type of cell death in which the cell uses specialized cellular machinery to kill itself, a cell suicide mechanism that enables organisms to control cell number and eliminate cells that threaten the animal’s survival.The apoptosis mechanism is activated when two or more DRACOs crosslink on the same dsRNA. If viral dsRNA is present inside a cell, DRACOs will bind to the dsRNA and induce apoptosis of that cell. If viral dsRNA is not present inside the cell, DRACOs will not crosslink and apoptosis will not occur.As the mechanism used by DRACO is to target the viral host cells rather than the viral proteins or genetic material directly, it is believed that there are very rare chance for them to develop resistance against the new drug. DRACOs have the potential to be effective therapeutics or prophylactics for numerous clinical and priority viruses, due to the broad-spectrum sensitivity of the dsRNA detection domain, the potent activity of the apoptosis induction domain, and the novel direct linkage between the two which viruses have never encountered. Due  this novel model of operation, scientific community expects that this new drug could be effective against all viruses, at least in theory.

Researches have published the results of experiments on mice only and they are planning to go ahead with higher animals and if found promising, advance towards human trials. As the drug research takes a long time, it is expected that DRACOs will take another 10 years to be declared safe and effective in human beings.

References.

1.    www.medicalnewstoday.com/articles/232632.php

2.    www.huffingtonpost.com

3.    www.godlikeproductions.com

4.    www.sciencecodex.com

5.    www.topix.com

ASLAM ARGODAN

FIRST YEAR PHARMACY PRACTICE

ALSHIFA COLLEGE OF PHARMACY

HAART A DAY KEEPS AIDS AWAY

Bone marrow transplant cures HIV

Novel gene therapy for HIV(Bone marrow transplant 'cures HIV patient' )

Muhammed Ishad*,Megha.M, Nayanathara P.S, Dilip.C, P.N. Krishnan, Junise.V

Al shifa college of pharmacy, poonthavanam, perinthalmanna,kerala.

Abstract

The "Berlin Patient" -- now known to be Timothy Ray Brown -- remains free of any detectable HIV in his blood, gut tissue, and other reservoir sites 4 years after receiving a bone marrow transplant containing stem cells from a donor with the CCR5-delta32 mutation, according to a report in the December 8, 2010 advance online edition of Blood. These findings, his doctors say, "strongly suggest that cure of HIV has been achieved in this patient."

INTRODUCTION

Two million people die of Aids every year and HIV is estimated to have infected 33 million people worldwide. [1] Doctors in Germany say a patient (42-year-old patient was an American living in Berlin) appears to have been cured of HIV by a bone marrow transplant from a donor who had a genetic resistance to the virus [2]. The researchers in Berlin said the man, who suffered from leukaemia and HIV, had shown no sign of either disease since the transplant two years ago.HIV requires one of 2 co-receptors, CCR5 or CXCR4, to enter human cells. Individuals with a natural genetic mutation known as CCR5-delta32, who do not express CCR5 on their CD4 T-cells, are resistant to HIV infection.[3] Those who do become infected may be "elite controllers" who maintain very low viral load without antiretroviral therapy (ART).

CASE STUDY

A berlin HIV +ve Patient underwent leukemia treatment that involves using potent chemotherapy to kill off immune cells -- which eliminates the cancer -- and reconstituting the immune system with donated hematopoietic stem cells, which differentiate into all the different types of blood cells, including T-cells.After the first transplant, researchers were unable to find any evidence of HIV, even though the patient stopped taking ART. He then received a second transplant from the same donor due to a relapse of leukemia. He had been infected with the human immunodeficiency virus, that causes Aids, for more than a decade and also had leukaemia. The clinic said since the transplant was carried out 20 months ago, tests on the patient's bone marrow, blood and other organ tissues have all been clear.

RESULT

"Results demonstrate successful CD4+ T-cell reconstitution at the systemic level as well as in the largest immunologic organ [the gut] following CCR5-delta32/delta32 stem cell transplant, and additionally provide evidence for the reduction in the size of the potential HIV reservoir over time," they elaborated in their discussion.

 The Berlin Patient, however, shows no evidence of residual HIV and has not experienced disease progression.

 His immune system was successfully reconstituted, and now contains HIV-resistant CCR5-delta32 cells, like those of the donor.

Furthermore, the researchers noted, "We found evidence for the replacement of long-lived host tissue cells with donor-derived cells indicating that the size of the viral reservoir has been reduced over time."

CONCLUSION

Although the recovered CD4+ T-cells are susceptible to infection with [CXCR4] HIV infection, the patient remains without any evidence for HIV infection since more than 3.5 years after discontinuation of ART," the researchers concluded. "From these results, it is reasonable to conclude that cure of HIV infection has been achieved in this patient."

References.

1)      Fauci AS,Lane HC.Human immune deficiency virus disease: AIDS and related disorders.In: Kasper,Braunwald,Fauci,Hauser,Longo,Jameson,Harrisons principle of internal medicine 17^th ed. Newyork Mc Graw-Hill; 2005.p.1137-1148

2)      Shelburne SA,Visnegarwala F,Darcourt J,Graviss EA,Giordano TP,White AC Jr,

      et al. Incidence and risk factors for immune reconstitution inflammatory syndrome                during highly active antiretroviral therapy.AIDS 2005,19:399-406

3)      http://www.german+bone+marrow+HIV&ei=ibswTpjrLc7hkAXP45HtAg&ved=0CBEQFjAE&hl=en&source=m&rd=1&u=hivandhpatitis/recend/2010/1214_2010_b.html

Muhammed Ishad,

M Pharm 1st year

Alshifa college of pharmacy,

Dilip.c

Associate prof

Alshifa college of pharmacy

Department of pharmacy practice,Al shifa college of pharmacy

DEPARTMENT OF PHARMACY PRACTICE

The mission of the Department of Pharmacy Practice in Al Shifa hospital is to

1) Prepare students for entry into the pharmacy profession in an environment that supports and inspires critical thinking, life-long learning, leadership and professionalism

 2) Create and disseminate knowledge related to the rational use, delivery and access to drugs and other therapeutic modalities and 3)Provide service and leadership to the university community, the profession of pharmacy and the public related to education and the optimal use of medications

About the Department

The Department of Pharmacy Practice is an academic department in the Al Shifa College of Pharmacy located in kizhatoor campus under Calicut University and also has facilities in Al Shifa Hospital in Perinthalmanna. The mission of the Department of Pharmacy Practice is to demonstrate excellence through performance in the areas of discovery, learning, and engagement.

The Department of Pharmacy Practice supports the College of Pharmacy's vision by:

* Providing education to students that enable them to acquire in-depth expertise in the pharmaceutical, social/economic management, and related sciences in order to function as educators and scientists in higher education, government service, and the pharmaceutical and healthcare industries

* Serving the community by engaging in scholarly activities that lead to improvements in healthcare delivery and enhance health outcomes

* Fostering innovation in research through interdisciplinary collaboration with other schools/colleges within other national/international universities, and pharmacy practitioners to enhance to profession body of knowledge resulting in practice advancement

* Contributing to the profession of pharmacy by participation in leadership roles in pharmaceutical organizations and community programs

DILIP.C

ASST PROFESSOR

ALSHIFA COLLEGE OF PHARMACY

PERINTHALMANNA, KERALA

pharm D in India.,Al shifa college of pharmacy

Pharm.D

As a part of our expansion programme and with a mission to serve the community as a whole, We have introduced Pharm D in Alshifa College of pharmacy, which to our expectation will produce more number of trained quality pharma professionals in coming years. We have ample infrastructure focusing mainly on clinical aspects. The introduction of the Pharm D. course is set to change the country’s pharmacy education landscape.  The introduction of Pharm.D, a six year integrated postgraduate programme, is expected to take the country’s pharmacy education to international levels. Pharm D. is a six year course providing intensive training in pharmacy practice and clinical pharmacy services.  The course will include five years of clinical and community-based theory with ward rounds and one year internship in hospitals.  Pharm D. students will work in coordination with doctors to treat patients.  In the final year, the student will come out as a clinical pharmacist who will be an essential component of healthcare equal to doctors. Pharm D. graduates will study in detail about drugs for different diseases, will advise patients about dose, action, and side effects and has knowledge and skills of current diagnostic methods, treatment modalities, drug delivery system, therapeutics outcome, pharmaco economics and pharmaco therapy to meet the rapid changes in the healthcare system. 

 A pharmacist is a vital link in the physician-patient chain and he is expected to play a key role in the dissemination of pharmaceutical knowledge. The practice of pharmacy includes the custody, preparation and distribution of pharmaceutical products besides providing advice on health and nutrition related issues. Al Shifa College of Pharmacy at Perinthalmanna in Malappuram district is the only college in the State to get the PCI approval this year. We are the only college in kerala giving 50% Govt merit seat for poor and meritorious students for improving the health care status of the state .Alshifa college is attached to a 450-beded tertiary care referral hospital. 

 The final outcome of the Pharm.D course

1. Pharmaceutical care to patient by integrating pharmacy into every day functioning of                  hospital and patient care, to be an essential part of heath care team.

2. Developing and managing medication, distribution and control systems. Further ensure                  correct storage, expiry dates and maintenance of documentation.

3. Maintaining of patient after medication, analyzing, reporting medication errors. Preparing                 policies, procedures for safe use of high risk medication, blood products, chemotherapeutic     agents, radioactive isotopes, investigational new drug and medicinal gases.

4. Promoting public health, patient counseling, and food drug interaction drug drug interaction.

  providing drug information, poison information, education to health care team and stake                              holder (patients)

5. Managing the pharmacy.

Dilip.c

Asst professor

Al-shifa college of pharmacy

perinthalmanna, kerala.