Q&A with Dr. Peter Aupperle, Senior Medical Director,
Noven Pharmaceuticals for Salonpas ®
1. What is a transdermal patch and what are the advantages of transdermal drug delivery
versus other types of medication delivery for pain management?
A transdermal patch is a medicated adhesive patch that is placed directly on the skin to deliver a
specific dose of medication through the skin. Transdermal drug delivery has advantages over other
medication delivery routes including oral, as the transdermal patch provides controlled release of the
medication into the patient as one’s body heat melts thin layers of medication embedded in the
adhesive. This medicine is absorbed right at the site of pain, so unlike pills that need to go through the
stomach and liver then spread out all over the body, topical treatments can use less medicine and get
the same or better relief.
2.
Is a transdermal patch more effective than a pill for pain management?
Using a transdermal patch or other topical medication like a spray or foam represents a welcome
alternative for pain sufferers including those who prefer to avoid the use of oral over-the-counter
(OTC) pain relief medication labeled for minor aches and pains. Unlike medications from pills which
go through the stomach then the liver and pass through your blood system to the pain, the
transdermal pain patch goes direct to the site of your pain, right where it hurts.
Most people don’t know that pills provide a lot of medication to the body. They have to because the
liver is the body’s filter and it knocks out about one third of the medicine. Then it has to spread that
medicine all over the body because your body doesn’t know that you are only trying to treat one
particular body part or spot. With a topical, you can deliver much less medicine to the body because
you’re applying it right at the site of pain.
Additionally, with all of the recalls that have happened lately with oral pain relievers, I find that my
patients are looking for something that is safer and offers lower side effects.
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3. Why is the Salonpas® Pain Relief Patch different from other pain relief products
available over the counter (OTC)?
Quite simply, the Salonpas® Pain Relief Patch and the Salonpas® Arthritis Pain product is the first and
only FDA-approved OTC pain relieving patch. They feature methyl salicylate (10%) and menthol (3%)
– two powerful topical analgesics – which goes right to the site of pain. These control released
products are clinically proven to reduce inflammation and relieve mild to moderate pain for up to 12
hours. Competitive products on the market can only relieve mild pain and provide pain relief that lasts
up to eight hours. Plus, the Salonpas patches are thin, comfortable and flexible making them easy to
wear – even on joints; something my patients enjoy over creams that tend to be messy and wear off
quickly.
4. Are the Salonpas Pain Relief products the only patches to be approved for over the
counter sale by the FDA under their New Drug Application process?
Yes, the Salonpas Pain Relief and Salonpas® Arthritis Pain Patch was approved by the United States
Food and Drug Administration (FDA) on February 20, 2008 and stands alone as the only OTC pain
patch to have FDA approval. This represents the first successful U.S. regulatory program for a nonprescription topically applied external analgesic product and is a marketing milestone for this category
of nonprescription products.
In the mid 1990’s, Hisamitsu became aware of the FDA’s escalating concerns with topical analgesic
patch products. Hisamitsu requested a series of meetings with the FDA to discuss their concerns and
to determine the regulatory program (including nonclinical and clinical studies) required to confirm the
safety and efficacy of these formulations. Hisamitsu conducted the necessary studies over a ten year
period and was able to secure the first FDA approval for this category of drug products in February
2008. Hisamitsu is the only manufacturer to submit and secure FDA approval for an NDA providing a
nonprescription topical patch delivery system containing external analgesic products.
5. What types of pain can the Salonpas patches alleviate?
The Salonpas patches are proven to work on mild to moderate pain and are great for muscle and joint
pain, arthritis pain, shoulder pain, back pain, neck pain and strains, sprains and bruises.
6. What are the real differences between moderate and mild pain?
According to the medically recognized pain scale, which shows comparative pain scale from 1 to 10
(the chart is included in this kit); moderate pain “interferes with many activities and requires a
lifestyle change with the person being unable to adapt to pain.” Minor pain “does not interfere with
most activities” and the person is “able to adapt to pain psychologically and with medication or devices
such as cushions.” Moderate pain is classified as “distressing,” “very distressing” and “intense.”
Hence, an OTC pain patch that can alleviate moderate pain that empowers a person to engage in
normal activities is quite significant.
Media contact: Nancy Tamosaitis, Vorticom, Inc. 212.532.2208 (o); nancyt@vorticom.com P a g e | 2
7.
Is there an ingredient from hot peppers that can help reduce pain?
Yes. Capsaicin is an ingredient found in some hot peppers, including cayenne peppers, which makes
the peppers spicy hot. When capsaicin is used on the skin topically, it helps relieve pain by first
stimulating and then diminishing the intensity of pain signals in the body. While it may seem to create
heat on the skin, the temperature of the treated area doesn’t increase (like if you were to use a hot
water bottle). That warming sensation is due to the increased blood flow to the area which helps in
pain management.
The Salonpas Pain Relieving Gel-Patch HOT-L represents another medical advancement in patch
therapy as it features capsaicin (0.025%) and menthol (1.25%) in a soothing cloth that is ideal for
minor aches and pain relief in the shoulder, upper back and lower back.
8.
Tell me about the new jet spray and massage foam products.
Hisamitsu Pharmaceutical has recently introduced the Salonpas® Pain Relieving Jet Spray and
Salonpas Pain Relieving Massage Foam products. The Jet Spray, that contains two powerful active
ingredients- 3% menthol and 10% Methyl Salicylate - is excellent for fast relief of muscle pain and
fatigue. The jet spray has a strong cooling effect from the use of a highly pressurized jet force. It
sprays on easily, without any greasy feeling and there is no need for rubbing. It’s a convenient
medication to tuck into a gym or sports bag.
The Salonpas Pain Relieving Massage Foam is what I recommend for tough pain. It also contains
two powerful active ingredients, 3% menthol and 10% Methyl Salicylate, which combined with a selfmassage provides a topical analgesic for the temporary relief of minor aches and pains of muscles
and joints associated with strains, sprains, bruises, simple backache and arthritis pains.
9. What is the market size of the nonprescription pain relief marketplace?
In the United States, the nonprescription pain relief marketplace exceeds $2 billion per year for oral
and topical dosage forms including tablets, capsules, ointments, gels, creams and patches.
10. Are transdermal and other topical drug therapy more common in Europe and Asia than
the United States?
Yes, while transdermal drug therapy is common in Europe and Asia, the United States is still
predominately a pill culture. Unfortunately, however, when people self-medicate with over-thecounter pain pills, they run the risk of potential drug interactions that can lead to unintended or
unsuspected dangerous side effects such as kidney failure or heart damage. Transdermal means
through the skin, and with mild to moderate pain, this means the use of a medicated patch that is
affixed to the skin. A transdermal patch is designed to deliver control released medication slowly
Media contact: Nancy Tamosaitis, Vorticom, Inc. 212.532.2208 (o); nancyt@vorticom.com P a g e | 3
through the skin for a long period of time. By relying on transdermal pain patches for pain relief,
without the use of pills, you can be assured of being compliant and safe,
While taking an acetaminophen pill for pain is safe when following directions, an overdose can occur
as the result of a single intentional or accidental one-time overdose. Chronically taking a dosage of
acetaminophen that is too high can also result in overdose. Acetaminophen is also a common
ingredient in a wide variety of non-prescription and prescription products, and accidental overdose is
often the result of taking multiple products that contain this ingredient. Even though it is safe when
taken appropriately, it can be very dangerous if you take too much, overdoses can lead to death or
liver damage.
Similarly an overdose of ibuprofen can cause life-threatening heart or circulation problems such as
heart attack or stroke, especially if used long term and may also cause damage to the stomach or
intestines, including bleeding or perforation. These conditions can be fatal and can occur without
warning while a person is taking ibuprofen, especially in older adults.
Consumers must remember that just because it’s available over the counter, it doesn’t mean that it’s
not strong medicine. And like all medications, they need to be taken as directed.
11. What is the connection between moderate pain and emotional distress?
Pain is a complex experience that includes both psychological and physical factors. Moderate pain
can lead to heightened emotional reactions including fear and anxiety. Intense moderate pain can
result in someone having trouble maintaining a job or normal social relationships. Moderate pain can
make a person so preoccupied with managing and noticing the pain that their normal lifestyle is
curtailed.
12. What is Noven Pharmaceutical’s relationship with Hisamitsu Pharmaceutical, the
manufacturers of Salonpas?
In July 2009, Noven Pharmaceuticals, Inc. was acquired by Hisamitsu Pharmaceutical Co. This was a
great fit as Noven is a specialty pharmaceutical company engaged in the research, development,
manufacture, marketing and sale of prescription pharmaceutical products. Noven’s business and
operations are focused in three principal areas – transdermal drug delivery, the Novogyne
Pharmaceuticals joint venture, and Noven Therapeutics. The merger allows us to offer more products
and technologies that meaningfully benefit patients, its customers and its industry partners.
13. Tell me about Hisamitsu Pharmaceutical.
Founded in 1847, with headquarters in Tosu and Tokyo Japan, Hisamitsu Pharmaceutical Co., Inc.
www.hisamitsu.co.jp, is a leading pharmaceutical company that develops and markets ethical and
over-the-counter (“OTC”) pharmaceutical products using transdermal drug delivery system technology
(TDDS). Hisamitsu has specialized in transdermal drug delivery system technology since the
introduction of its original line of patches in 1934. Hisamitsu’s Salonpas brand of product is exported
to over fifty countries.
14. Where are Salonpas products found?
In the United States, the Salonpas line of products are sold in all major drugstores and retailers and
can purchased online at dozens of online retailers including Drugstore.com and Amazon.com.
Media contact: Nancy Tamosaitis, Vorticom, Inc. 212.532.2208 (o); nancyt@vorticom.com P a g e | 4
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Media contact: Nancy Tamosaitis, Vorticom, Inc. 212.532.2208 (o); nancyt@vorticom.com P a g e | 5