The company, Optimal Pain Control, or OPC, is the brainchild of pharmacist Robert Gussenhoven and harkens back to the day when pharmacists made the compounds doctors prescribed.
“Compound pharmacies” are becoming increasingly popular. they range from adding flavoring to cough syrups to combining off-the-shelf, federally approved medicines to produce customized therapies for patients.
OPC focuses on pain medications that are smeared — known as topicals — rather than swallowed that pharmacists say have no risk of addiction and few side effects.
Drugs delivered through the skin generated an estimated $5.6 billion in 2009, according to a report from Market Research News, an independent research firm.
“Innovative technologies that are able to deliver drugs with a broader spectrum of characteristics are poised to revolutionize the transdermal drug delivery market and drive significant growth,” the report states.
Unlike drug companies that invest millions into developing new brand-name drugs, compound pharmacies such as OPC capitalize on the thousands of available drugs that have already been tried and tested.
Until the mid-1940s, pharmacists only created prescriptions through compounding. The end of World War II ushered in the era of big science and compounding fell out of favor, said David Miller, executive vice president with the International Academy of Compounding Pharmacists, a trade organization.
Compounding made a resurgence in the mid-1990s at a time when big pharmacies started to inundate consumers with direct advertising and realized the aging population metabolized drugs differently than the general population.
“At the time, consumers started asking for things from their pharmacists such as ‘is this right for me?’ ” Miller said.
The compounding industry now makes up an estimated 1 to 3 percent of the U.S. prescription market, which is worth $300 billion overall. of the 56,000 pharmacies, approximately 7,500 specialize in compounding, an expensive proposition because of specialized equipment costs.
In rare cases, the popularity of a drug can indirectly cause its price to skyrocket in compounds. In March, KV Pharmaceutical got FDA approval for a drug, hydroxyprogesterone, to prevent pre-term labor.
The drug already had been used by compounders and cost about $15 per injection, but with FDA approval, the pharmaceutical company could charge $1,500 per injection.
“Drug companies are picking up on these old drugs that are being compounded and putting them through the FDA approval process,” Miller said. “they set up their pricing at a level that is substantially higher than when it was compounded.
“We really want to foster innovation, and we really want to stimulate research, but if we’re granting approval of drugs that have not involved innovation research, are we doing our health care service a disservice?”
Hydroxyprogesterone is just one of many compounded drugs that has skyrocketed in value, Miller said, but it still represents a rarity.
Alabama has five compound pharmacies accredited through the Pharmacy Compounding Accreditation Board. OPC is not accredited, but officials say they are seeking the seal of approval.
Compound pharmacies are limited in that they can’t make an exact medical claim because the compound hasn’t gone through clinical trials.
“The idea of topicals for pain relief is not new — our formulations is what’s novel,” said Ashley Morrow, director of marketing and human resources with Optimal Pain Control.
With thousands of formulations available and new pain drugs constantly becoming available, however, the competition is intense.
“In a year from now, the topicals we do will be obsolete,” Morrow said. “having these competitors validates our market, but if you don’t advance the formulas, you’ll bite the dust.
“if we find something better,” Morrow said, and then snapped her fingers, “We can change the formula overnight.”
During a lab tour, lab supervisor Jeremy Sherrill talks through an obligatory face mask. three technicians overlook the production that resembles a high-tech kitchen.
The cream includes 15 to 22 proprietary ingredients the pharmacists say helps drive medicines from the skin’s surface to the inside.
Down the hall, Morrow shows a “brag wall” where customers attest to the use of the topical pain medications personalized for their symptoms.
Larry Alton, a family and sports medical doctor in Montrose, Mich., not only uses the compound medicine in his practice, but is a patient himself.
Alton had several surgeries on his back and a damaged nerve in his leg. He worked four days a week. By the end of the week, Alton said he could barely stand up.
“I don’t take pain pills because of what I do for a living; I pretty much had to suck it up and do nothing,” Alton said.
“I tried the cream as directed and was a bit skeptical only because I’ve tried other topicals before and non-prescription topicals,” Alton said. “within about 12-15 minutes, I experienced probably more than 50 percent relief and the relief lasted eight to nine hours.”
Now Alton works a full five-day schedule and sings in a band.
Tim Aaron, chronic pain consultant and co-owner, said with pain-relief creams spread on the skin — also known as transdermals — “there’s no playbook out there — we’ve done a lot of learning by mistakes and errors.”
Trevor Stokes can be reached at 256-740-5728 or .