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Although clinical practice guidelines for
Specialty Pharma Opportunities
the prevention and treatment of CINV haveimproved over time, actual adherence in this
in Cancer Supportive Care:
regard lags behind (Figure 1). Improvementin risk assessment and stricter adherence toguidelines for the prevention and management
A Look at Anti-Emetic Therapy
of both acute and delayed CINV, particularlyfor initial courses of treatment, may ultimatelylead patients to an improved quality of life
By: Suresh Borsadia, President & CEO; and
during therapy, a reduction in time spent by
healthcare providers addressing CINV, and
Strategic Planning & Alliance Management,
patients to optimal therapeutic doses for themanagement of their disease.4
treatment for their disease because of the
quality of life caused by CINV, ultimately
phases: acute, delayed, and anticipatory.5
common and distressing side effects of cancertreatment. The current market size of CINVtherapeutics is more than $1.5 billion in theUS alone.1 An estimated 70% to 80% of
patients receiving chemotherapy experiencesome level of nausea and vomiting.2 AcuteCINV significantly reduces quality of lifeduring treatment, and delayed CINVcontinues to be an issue after patients return
home following their treatment, affecting
their ability to perform daily activities.
Furthermore, metabolic disturbances, suchas electrolyte imbalances and/or dehydrationmay occur due to CINV, as well as tearingof the esophageal mucosa, rehospitalization,increased medical costs, and increased time
commitments by healthcare providers forthe management of events caused by CINV.
However, one of the most disconcerting
consequences of CINV is the tendency of upto 50% of the patients to refuse subsequent
Chemotherapy-Induced Emesis Nausea & Vomiting (CINV) – Impact on Health-
Related Quality of Life.
efficacy of the 5-HT3s in acute emesis.
induced by a highly emetogenic drug, while
Delayed emesis on the other hand, seems to
treatment; delayed CINV is defined as nausea
and/or vomiting that occurs after the first
substance P/neurokinin(NK)1 receptors –
24 hours of treatment and up to 120 hours
emesis. Although it was previously thought
following treatment; and anticipatory CINV
receptor antagonist (aprepitant – Emend®)
that 5-HT3 inhibitors were only useful in
is defined as nausea and/or vomiting that
occurs prior to the delivery of subsequent
inhibitor Aloxi® is the first approved drug in
Incidence of CINV
its class for the prevention of delayed CINV.
This benefit is likely due to palonosetron’s
optimal prophylactic anti-emetic therapy;
& Current Treatments
longer half-life and high receptor binding
however, breakthrough emesis is difficult to
researchers have questioned whether Aloxi’s
physicians and nurses routinely underestimate
the incidence of delayed nausea and vomiting
pharmacologic or simply a carryover effect.
inadequate prophylactic anti-emetic therapy.
between the perceived incidence versus the
scientific explanation because there is no
body of evidence to show that palonosetron
contributing to its development, several of
which are currently under investigation. It is
the other 5-HT3 inhibitors. Hence, a drug
and may not be reporting the side effect to
vomiting are two distinct entities. Nausea is
sustained levels up to 5 days for any of the
Several different types of anti-emetics are
a feeling characterized by the urge to vomit.
available today, including 5-HT3 receptor
antagonists, corticosteroids, D2 receptor
keeping the 5-HT3 receptors saturated, and
antagonists, and NK-1 receptor antagonists,
sensation, often accompanied by tachycardia,
should show benefits in delayed emesis.
sweating, flushing, and/or restlessness.
Vomiting is the actual propulsion of stomach
antagonist, represents a new class of anti-
contents through the esophagus and out of
development in the 1990s of 5-HT3 inhibitors,
2004 to be used in combination with other
peripheral and central sites from binding of
interactions between neurotransmitters and
receptors located in both the peripheral and
central nervous systems. Several different
chemotherapy, including high-dose cisplatin.
inhibitors are highly effective in prevention
including serotonin, dopamine, acetylcholine,
or management of acute CINV, particularly
The Need Today — Prevention
histamine, and substance P to name a few.
Acute emesis is hypothesized to originate
chemotherapy agents. A comparative summary
extremely important in maintaining a patient’s
of the 5-HT3 inhibitors is provided in Table 1.
gastrointestinal (GI) tract post-chemotherapy,
quality of life. However, the optimal strategy
leading to stimulation of the 5-HT3 receptor
in the central nervous system, which triggers
acute and delayed CINV in the initial course
a nauseaus reflex – hence, the usefulness/
of treatment, rather than treating the problem
once it has occurred. First, quality of life and
patient compliance to further treatment may
be maintained if CINV prevention occurs in
Comparison of 5-HT3s
the initial courses of therapy. In addition,
preventing CINV can help to reduce medical
cost and the burden of managing CINV.
Second, prevention of CINV in the initial
course of therapy may lead to reduced CINV
experience of CINV with initial courses of
• Preventive treatment option that provides protection
• Could be easily removed if there is any adverse
• Requires specialist healthcare provider for
• Requires surgical procedure if removal is
necessitated due to any adverse effect from therapy.
• Short duration of action, limited if any, use in
• Patient acceptability and taste could present a
• Short duration of action, limited if any, use in
• Taste-masking could be a major challenge.
• Design increases product cost and complexity of
administration with no apparent benefits over a
treatment protocols to determine the risk
agents are considered moderately emetogenic
of their patient developing CINV.10 Once a
patient’s risk is determined, healthcare
clinical studies. Risk assessments help to
determine which patients are at a higher risk
< 10% frequency of emesis
protocols according to established guidelines.
10% to 30% frequency of
that if CINV is uncontrolled, there is: 1) a
patients who are identified through the risk-
reduction in scores in cognitive function;
30% to 60% frequency of
assessment models may be strictly managed
dyspnea; and 6) poor overall quality of life.
specified guidelines. Patients identified at
idarubicin, ifosfamide, IL-2, irinotecan,
also be treated for the prevention of CINV,
week on the telephone with their patients at
>60% to 90% frequency of
The most commonly identified risk factors
nurses to have more time to tend to other
emesis (amifostine, busulfan, carboplatin,
for developing chemotherapy-induced emesis
agents used in treatment; 2) prior CINV;
3) female patients; 4) younger patients;
>90% frequency of emesis
possess? The consensus is that an ideal anti-
is classified into 5 levels according to the
(carmustine, cisplatin, cyclophosphamide,
emetic would provide: 1) complete control in
all settings; 2) no side-effects; 3) convenience
and ease of use; 4) fewer drug interactions;
emetogenic agents listed further are from
It is important for healthcare providers to
5) a simpler dosing regimen; and 6) no cost
the National Comprehensive Cancer Network
properly assess their patients and intended
products being developed for CINV are drug
delivery systems incorporating existing 5-HT3
Specialty Pharmaceutical company active in
reformulations, along with their key features
the supportive cancer segment, because in
are shown in Table 2. It is apparent that a
addition to CINV, there exist significant
transdermal anti-emetic product comes closest
opportunities in radiation-induced nausea
to satisfying the profile of an ideal anti-
and vomiting (RINV) and in post-operative
emetic product. Abeille Pharmaceuticals, Inc.,
has a transdermal anti-emetic product at an
advanced stage of development. Some of the
advantages of a transdermal product include:1) an ideal mode of treatment for cases
1. Taller D. Analyst Report from Cathay Financial,
Mr. Suresh Borsadia has more than 14 years
where the need for the anti-emetic therapy
experience in the pharmaceutical and drug
extends beyond 1 day, since the patch will
2. Ettinger DS. Chemotherapy-Induced Nausea and
delivery industries, with expertise and experience
Vomiting (CINV). An update from ASCO; 2004.
be designed to deliver the drug for up to 5
in R&D and business/corporate development
days; 2) protecting the patient through the
3. www.cancernausea.com – a website for people
activities. Mr. Borsadia has a demonstrated
experiencing nausea and vomiting caused by
chemotherapy until the patch is removed; 3)
projects and building R&D organizations in early
4. Buckner CD, Maxon J. Chemotherapy-Induced
maintaining blood levels of the drug in the
stage companies. Prior to founding Abeille
Nausea and Vomiting (CINV): An update from
the Oncology Nursing Society (ONS)
Pharmaceuticals, Inc., he was with Lavipharm
therapy. In addition, the blood levels of the
for 7 years, where he played a leading role in the
company’s R&D, in-licensing, and out-licensing
drug will continue in the therapeutic range
5. ASHP Therapeutic Guidelines on the
Pharmacologic Managemnet of Nausea
activities. He was part of the Senior Management
several hours post removal of the patch; 4)
Am J Health Sys Pharm.
team involved in M&A and fundraising activities.
increasing patient confidence in the ability
Prior to that, he worked at two other leading
to leave the hospital or the doctor’s office
6. Ellis RJ, Jr. Analyst Report from Leerink Swann
drug delivery companies, TheraTech, Inc.,
(now Watson Pharmaceuticals), and Bertek, Inc.,
knowing that they will not require further
7. Grunberg S, et al. Incidence and impact of
(now Mylan Technologies, a Division of Mylan
intervention for side-effects; 5) improving
nausea/vomiting with modern antiemetics:
Labs.). His professional background is in
perception vs. reality. Cancer. 2004;100:261-268.
removing the need for an oral administration
8. Gralla R. New antiemetic agents.
Hematol Oncol. 2005;3(5):350-352, 382.
of an anti-emetic during a time period whenthe patient may not want to ingest anything due
9. National Comprehensive Cancer Network,
to discomfort; 7) helping reduce anticipatorynausea in subsequent chemotherapy treatments;
10. Lindley CM, et al. Quality of life consequences
Kalpana Patel, PhD
of chemotherapy-induced emesis.
Qual Lif Res.
and 8) easily removed by the patient if there
is any adverse effect due to the therapy.
Strategic Planning & AllianceManagement, AbeillePharmaceuticals, Inc.
Dr. Kalpana Patel has more than 12 years of
experience in the pharmaceutical industry and
has led preformulation, formulation, process
development, and validation initiatives for a
range of Rx, Rx to OTC switches, OTC products,
and medical devices. Dr. Patel most recently
was the Pipeline Development Director for
Johnson & Johnson Consumer Companies.
During her tenure at J&J, she held leadership
responsibilities involving product development,
life cycle management, and was involved in
advisory meetings with thought leaders. In
addition, she was actively involved in interaction
with global regulatory bodies. While at J&J, she
also founded the Johnson & Johnson community
Perceptions & Reality - Moderately Emetic Chemotherapy.
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