we are proud of you tony!

i can hardly stand it...my good friend adena - her husband...who i always say i would love to clone...has been working diligently to get fda approval on a patch that will help with pain from shingles...this has been years and years in the making...

they have received fda approval!!

my aunt suffers from this pain...so i have seen it first hand...and it ain't pretty...

it is so exciting to be so close to the action and excitement...we are all so proud of tony...as adena says..."my husband is a rockstar!"

here is an article written on bioworld today...this is the "variety" in pharma business...and a front page spread on top of it...

congratulations tony!!

Don’t Hold the Chili Peppers:
NeurogesX Patch Gets FDA OK

By Donna Young
Washington Editor

NeurogesX Inc. won FDA approval of the firm’s synthetic
capsaicin patch Qutenza as a therapy to manage a
form of nerve pain that often persists long after a bout of
shingles, known as postherpetic neuralgia (PHN).
Capsaicin is what makes chili peppers hot and has
long been used as an ingredient in topical therapies for pain.
But NeurogesX, which developed Qutenza internally
without a partner, is the first company to gain U.S. marketing
approval of a prescription product that delivers a high
dose of synthetic capsaicin.
While the concentration of capsaicin in the Qutenza
patch is 8 percent, other marketed capsaicin-containing
products, which generally are available as creams or gels,
come in much lower concentrations of about 0.025 percent
to 0.075 percent, noted NeurogesX CEO Anthony DiTonno.
The lower-concentration capsaicin creams and gels
also must be applied three or four times per day for often
up to several weeks, “and patients simply won’t put up or
can’t tolerate having that burning and stinging sensation
on their skin” for that period, DiTonno told BioWorld Today.
The Qutenza pain patch, which is intended to be
applied by a health care professional in an outpatient setting,
such as a physician’s office or pain clinic, delivers the
prescription strength capsaicin in a single hour-long application
procedure and provides up to 12 weeks of reduced pain, he said.
The entire procedure lasts a little over two hours,
which includes an application of a topical anesthetic about
an hour before the Qutenza patch is applied, DiTonno explained.
The health care professional can cut the patches, which
come as 280-centimeter squares, to conform to the size
and shape of the area in pain, he noted.
The synthetic capsaicin in Qutenza works by targeting
C fibers, which are found in the peripheral nerves of the
somatosensory system, which sends the signals to the
brain about sensations.
Once delivered, the capsaicin binds to the TRPV1 receptor,
and in doing so, “basically desensitizes that nerve ending
for what we’ve seen in our clinical trials for up to about
three months,” DiTonno said.
And after a single 60-minute application of the patch,
he said, “the patients go home and don’t have to take any
pills,” such as opioid pain relievers, antidepressants or anticonvulsants
– the drugs typically prescribed to manage PHN.
While opioids, antidepressants and anticonvulsants
work well to relieve PHN, they come with several associated
adverse effects, such as drowsiness, somnolence, daytime
sleepiness, and also have been related to drug-drug
interactions, DiTonno said.
He noted that the average age of patients in the
Qutenza clinical trials was about 70 years.
“So you can imagine that those patients are taking perhaps
pills for blood pressure, arthritis and diabetes,” DiTonno said.
But with Qutenza, he noted, “not having to take another
pill is probably a big advantage.
“Our product works directly in the skin, and it doesn’t
get into the systemic circulation, so you don’t worry about
systemic side effects after the procedure,” DiTonno maintained.
Once patients are titrated up to a therapeutic level with
Qutenza, they experience about a 30 percent to 50 percent
reduction in pain, “and that is considered clinically relerelevant,” he contended.
DiTonno noted that Qutenza was developed in house
by NeurogesX, a 50-employee firm, based on the science
from the company’s founder, Wendye Robbins, a pain specialist
and professor of anesthesiology at Stanford University.
“Getting a product approved anywhere in the world is a
major milestone for Pfizer, Roche and Lilly,” he said. “But for
a team of professionals of around 50 people in San Mateo
to accomplish the same feat as these pharmaceutical
giants is something that we are very proud of. And hopefully,
people will make the translation that we are going to
be equally as efficient from a marketing and sales standpoint.”
While the length of time it took NeurogesX to get to
final U.S. approval was “on par for our industry,” the company
accomplished the milestone “with significant less
capital than the industry norm,” DiTonno said.
“This is, in essence, the efficiency of what a specialty
pharma company can accomplish and why we are so proud
of this event,” he declared.
DiTonno noted that Qutenza also was granted
approval in Europe in May.
Shortly after that European win, NeurogesX granted the
European, Middle Eastern and African rights to Qutenza to
Tokyo-based Astellas Pharma Inc. in exchange for $42 million
up front, under a deal that potentially could bring the
California firm more than $145 million. (See BioWorld
Today, June 23, 2009.)
While the approvals and the Astellas deal have made
2009 a “watershed year” for NeurogesX, “the hard work has
just begun” for the company on the sales and marketing
end before Qutenza’s U.S. launch in the first half of 2010, DiTonno said.
While NeurogesX over the past few months has been
laying the groundwork for that launch, “We have a lot to do
between now and then,” he said. But, DiTonno added, “we
have the people and the resources to do it, and are energized by the challenge.”
He said NeurogesX already is “well down the road” of
establishing its distribution channel.
“We have already completed the manufacture of and
expect to have product ready to go into that channel in
time to support our launch in the first half of 2010,”
DiTonno said. “And now that we have the approval in hand,
our vice president of sales is gearing up the process of first
hiring regional sales directors, and shortly thereafter, our sales reps.”
The company also is in the process of fielding its medical
science liaison team, which will be charged with educating
“key opinion leaders” on the use of Qutenza.
With the added sales and marketing personnel, said
Stephen Ghiglieri, NeurogesX’s chief financial officer, “it is
not out of the realm to think that we will close to double in
size within the next year.”