The Pharmaceutical Society of Australia has welcomed the Federal Budget
announcement to extend the cover of the Pharmaceutical Benefits Scheme to
appropriately qualified and credentialed nurse practitioners and eligible midwives.

Under the new arrangements, these senior nurses will be authorised to write
prescriptions for certain drugs that will attract all the benefits of the PBS for their
patients.

The National President of PSA, Warwick Plunkett, said the decision by the Government
would increase public access to quality health-care and free up doctors to perform more
critical medical duties.

“The nurse practitioners who are authorised to undertake these prescribing functions
are educated to a Masters level and are recognised as Nurse Practitioners by the nurse
regulatory authority in their State or Territory,” Mr Plunkett said.

“PSA understands that eligible midwives will be subject to similarly stringent standards.”

Mr Plunkett said the development of private practice/consultant nurse practitioners had
been restricted by the absence of PBS cover.

“Currently if authorised nurses did prescribe, the consumer would be charged full cost
for the medication,” Mr Plunkett said.

“This has been a major disincentive to the growth of the practice and a barrier to
equitable access for consumers.

“The decision to extend PBS cover to nurses prescribing medications is a commonsense
move which will enhance the wellbeing of consumers, including those living in
rural and remote areas.”

The PSA believes pharmacists are ideally placed, given their grounding in therapeutics
and quality use of medicines, to prescribe in the near future.

Source
Pharmaceutical Society of Australia

One reason antidepressant medication treatments do not work as well in real life as they do in clinical studies could be the limited type of study participants selected, researchers at UT Southwestern Medical Center have found.

“We are basing our judgment of clinical care in the United States on samples of patients that are totally different from the patient population actually treated in primary care and mental health facilities,” said Dr. Madhukar Trivedi, professor of psychiatry at UT Southwestern and senior author of a study published in the May issue of the American Journal of Psychiatry. “Antidepressants should not be seen as a panacea. The general belief is that they work well, but they are less effective in real-world practice, and more work is needed.”

As part of the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study scientists found that only 22 percent of the 2,855 participants treated with a commonly prescribed antidepressant would have met the criteria for inclusion in a typical antidepressant efficacy trial. Those who did meet criteria had shorter bouts of depression, quicker response to medication, less severe side effects and fewer adverse events compared with those people with depression who would have been excluded from such a trial, used to gain Food and Drug Administration approval of the drugs used.

The STAR*D trial was the first large-scale study to define the effectiveness of several treatment steps in primary care and mental health settings for people with depression, Dr. Trivedi said.

The six-year, $35 million STAR*D study is the largest investigation on the treatment of major depressive disorder and is considered a benchmark in the field of depression research. It initially included more than 4,000 people from outpatient treatment sites across the country. About 65 percent of STAR*D participants, however, had a medical co-morbidity such as diabetes that typically would have excluded them from participating in other clinical trials to test the efficacy of antidepressants, said Dr. Trivedi, co-principal investigator of STAR*D.

“Evidence is growing that depression is like other chronic medical illnesses where it’s not just one small, short bout, but a longer battle. People with depression may be at higher risk for other illnesses including obesity or diabetes, yet people with these conditions are excluded from drug trials for depression,” Dr. Trivedi said.

STAR*D provided evidence for step-by-step guidelines to address treatment-resistant depression. Many treatment-resistant depression patients would be excluded from drug efficacy trials because those trials typically eliminate study candidates who have previously tried treatment, have suicidal thoughts or have other psychiatric illnesses.

“These are the patients impacted by depression the most - highest suicide potential, highest unemployment rates, highest social impairment - and they are likely to produce poorer outcomes,” Dr. Trivedi said. “That population doesn’t get studied systematically in traditional pharmaceutical industry studies.”

More research involving patients routinely seen in clinical practice coupled with pharmacogenetics is sorely needed to better understand how to best match patients with specific antidepressant treatments, Dr. Trivedi said.

He recommended that clinicians continue to prescribe antidepressants but with more realistic expectations about the disease’s long-term nature. Dr. Trivedi said researchers should design future trials in real clinical practice settings where patients have co-morbidities, as he is doing in his current research.

Other UT Southwestern researchers involved in the study were Dr. Mustafa Husain, professor of psychiatry and internal medicine; and Drs. Diane Warden and David Morris, both assistant professors of psychiatry. Researchers from seven other medical institutions were also involved.

STAR*D is funded by the National Institute of Mental Health. Antidepressant medications were provided by Bristol-Myers Squibb, Forest, GlaxoSmithKline , King Pharmaceuticals, Organon, Pfizer and Wyeth.

Dr. Trivedi has received consulting or speaking fees from Abbott, Abdi Brahim, Akzo (Organon), AstraZeneca, Bristol-Myers Squibb, Cephalon, Eli Lilly, Fabre-Kramer, Forest, GlaxoSmithKline , Janssen, Johnson & Johnson, Meade Johnson, Neuronetics, Parke-Davis, Pfizer, Sepracor, Vantage-Point and Wyeth.

Source:
Lakisha Ladson

UT Southwestern Medical Center

Archimedes Pharma Limited, the UK based, pan-European
specialty pharmaceutical company, announces new positive headline
phase
III results for NasalFent(R), the Company’s innovative and highly
differentiated fentanyl citrate nasal spray, developed for the rapid
relief
of breakthrough cancer pain. The ground breaking phase III study compared
NasalFent to immediate release morphine sulphate, the most commonly
prescribed medicine for breakthrough cancer pain.

Breakthrough cancer pain affects up to 95% of all cancer
patients and is characterised by sudden, unpredictable episodes of intense
pain that occur despite background pain medication. This pain is rapid in
onset, often reaching maximum intensity in 5 minutes with a duration of
30-60
minutes.

NasalFent met the primary efficacy endpoint in the phase III
study 044. Patients treated with NasalFent showed a statistically
significant
improvement in Pain Intensity Difference within 15 minutes (PID15)
compared
to immediate release morphine sulphate (p < 0.04), meaning a greater
reduction in pain.

NasalFent is the only one of the new generation of fentanyl
products to have demonstrated statistically significant improvements over
immediate release morphine sulphate. Significantly better improvements in
pain scores for NasalFent versus immediate release morphine sulphate were
seen at all subsequent time points indicating that superiority of
NasalFent
was maintained for 60 minutes after dosing.

NasalFent showed both consistent effectiveness and high
acceptability; 94% of patients completed the double-blind part of the
study
and 70% of patients elected to continue therapy with NasalFent in the long
term Phase III safety study.

Professor Marie Fallon, St Columba’s Hospice Chair of
Palliative Medicine, University of Edinburgh, Edinburgh Cancer Research
Centre (CRUK) Western General Hospital Edinburgh, UK stated: “These data
are
hugely exciting. This is the first time a simple-to-use fentanyl product
has
been shown to be superior to the standard treatment for breakthrough
cancer
pain. NasalFent offers the prospect of greatly improving the management of
this distressing and common complication of cancer”.

Study 044 was conducted in all major western European
countries and in India, involving 35 expert investigational sites. A total
of
135 patients were screened and 110 (82%) entered the open dose titration
phase. 84 (76%) patients participated in the double-blind,
placebo-controlled
portion of the study. It is planned that data from study 044 will be
presented at scientific meetings later in 2009.

Richard de Souza, CEO of Archimedes, commented, “We are
delighted with these results from another innovative study of NasalFent in
what is the largest and most comprehensive clinical programme for any
breakthrough cancer pain product. These data clearly show that NasalFent
is
superior to the benchmark product for this condition and fully supports
the
results from study 043 which demonstrate that NasalFent offers pain relief
within 5 minutes of dosing and is highly acceptable to patients. Data from
our third phase III study, 045, a long-term safety study, including over
500
patients, will be available shortly.”

Phase III data on NasalFent confirming best-in-class profile
to be presented at major scientific congresses

Data from the phase III study 043 on NasalFent are to be
presented at the American Pain Society (APS) on 7 and 8 May by Professor
Allen Burton, Professor and Chair at the University of Texas and MD
Anderson
Cancer Centre in Houston, Texas, and at the European Association of
Palliative Care (EAPC) on 9 and 10 May by Dr Russell Portenoy, Chairman,
Department of Pain Medicine and Palliative Care, Beth Israel Medical
Center,
New York and Dr Donald Taylor, Medical Director and Anesthesiologist,
Georgia
Center for Cancer Pain Management & Palliative Medicine, Georgia.

Results covering both primary and secondary outcomes show
statistical superiority for NasalFent over placebo and provide robust
evidence for NasalFent as the first product to have demonstrated both
rapid
onset of pain relief within five minutes of dosing, and early clinically
meaningful pain relief within 10 minutes of dosing. Use of rescue
medication
was low confirming that NasalFent was also consistently effective.
Additional
data presented showed that NasalFent produced highly significant
improvements
across a range of pain assessments. Nasal tolerability was excellent and
side
effects were generally mild to moderate in intensity and importantly were
typical of fentanyl use in this patient population.

Professor Allen Burton, Professor and Chair at the University
of Texas and MD Anderson Cancer Centre in Houston, Texas, who participated
in
the study and is presenting the data at the APS, said: “Breakthrough
cancer
pain is a significant clinical issue and these data illustrate the
potential
for NasalFent to offer ultra-rapid, consistent pain relief to the many
patients who suffer from this unpredictable and extremely debilitating
pain.”

NasalFent

NasalFent is an innovative and highly differentiated aqueous
fentanyl citrate nasal spray utilising Archimedes’ proprietary PecSys(TM)
technology. NasalFent has a low viscosity and is easily delivered in a low
volume of 100mcl using a conventional nasal spray pump. The pump produces
a
fine mist of similarly sized spray droplets which are deposited into the
front of the nostril. The calcium ions present in nasal mucosal fluid
cause
the pectin to form a thin gel layer resulting in modulated drug
absorption,
allowing rapid but controlled absorption into the systemic circulation and
an
increased duration of action. PecSys technology avoids problems associated
with simple solutions used as nasal sprays such as supratherapeutic levels
of
drugs and dripping or swallowing of drug solution. NasalFent is in
development for rapid relief of breakthrough cancer pain.

Breakthrough cancer pain affects up to 95% of all cancer
patients and is characterised by sudden, unpredictable episodes of intense
pain typically lasting 30-60 minutes and which occur despite background
opioid pain medication. Initial Phase III data illustrates that NasalFent
has
a potential best-in-class profile among fentanyl products for breakthrough
cancer pain and is the first product to demonstrate onset of pain relief
within five minutes of dosing. NasalFent will be filed for regulatory
approvals from Q2 2009 and is targeted for launch from mid-2010.

Source
Archimedes Pharma Limited