The journey of FDA approval for a Silicon Valley product

 

Applying for FDA approval is similar to applying for a job. You fill out an application and cross your fingers.

For Redwood City-based AcelRx Pharmaceuticals, Inc., the process was no different. After filling out a New Drug Application (NDA) for its hand-held, pain management Zalviso product in September 2013, the company heard back from the FDA the following July. Its response? “Not yet.”

And just like the job application process, the FDA may ask an applicant to come back once they’ve acquired more experience. In lieu of an approval, the FDA may send back a Complete Response Letter (CRL) — which in the case of Zalviso — asked the company to complete more testing.

In 2014, the FDA’s Center for Drug Evaluation and Research (CDER) approved 41 novel drugs. This number is high considering that from 2005 through 2013 CDER has averaged only 25 novel drug approvals per year.

But a CDER stamp isn’t the only approval AcelRx has to worry about. The Zalviso product — a patient-activated, hand-held device that allows a hospital patient to self-administer pain medication — is a drug-and-device combination. This means the Center for Devices and Radiological Health (CDRH) also has a say.

Founder and chief medical officer of AcelRx Dr. Pamela Palmer said that since the main function of Zalviso is drug-related, the CDER takes control but uses CDRH as a consult.

Palmer said, “When you have a combination product, the complexity of approval seems to go up in an exponential manner, not just additive.”

Since approval for a drug-and-device combination is so difficult, the product holds more value once approval is achieved. The complexity of a combination product makes it difficult to undergo the Abbreviated New Drug Application process, which would allow others to market a generic version of the product.

“Generic manufacturers are more into cheap formulation plays and not complex electromechanical device development,” Palmer said. “So our intellectual property is critical for us since our protection out to 2027 and beyond is actually a real scenario, as opposed to many companies that face generic completion early on.”

But before the company has to worry about competition from generics, FDA approval has to come first. Before announcing 2014 fourth quarter earnings on March 9, AcelRx was notified by the FDA that it will need to complete another clinical trial. This will push back Zalviso’s resubmission from the company’s original intent to resubmit later this month.

Analysts such as Guggenheim Securities Senior Analyst Louise Chen, though, believe that despite the pushback from the FDA, it is unlikely for a product like Zalviso to become a generic product.

“We [think] Zalviso will have longer-than-expected brand exclusivity because drug-device combos are hard to genericize,” Chen said.

Editor’s Note: The video above was produced before March 9, 2015. Since then, the FDA has called for additional clinical testing on Zalviso, which could delay its approval.