Rodman and Renshaw analyst Raghuram Selvaraju, in a research report issued July 5, noted the FDA has decided not to hold an Advisory Committee (AdCom) meeting for DURECT Corp.'s (DRRX:NASDAQ) Remoxy, and to retain the Sept. 25 Prescription Drug User Fee Act (PDUFA) date.
"We believe this suggests that the efficacy and safety profile of Remoxy has been well presented in the NDA (new drug application) package, from the FDA's perspective. . .therefore, in our view, Remoxy is likely to secure regulatory approval in September," Selvaraju wrote.
Remoxy's abuse-deterrent formulation is key to its potential approval, Selvaraju notes. "Remoxy's thick, sticky, high-viscosity formulation may deter unapproved routes of drug administration, such as injection, snorting or smoking. Investors may know that oxycodone abuse and diversion remains a serious, persistent problem. Nearly 19,000 people died from opioid overdose in 2014, according to the National Institute on Drug Abuse."
Selvaraju believes that, given the deterrent formulation, Remoxy "should be able to seize a significant market share" from Purdue Pharma's OxyContin, which the analyst notes earns $2 billion in revenues annually.
DURECT and collaborator Pain Therapeutics could expect to "generate peak sales of over $300M a year," Selvaraju wrote. "DURECT is entitled to receive royalties for Remoxy ranging from 6.0% to 11.5% of net sales."
Remoxy addresses other issues that have surfaced with OxyContin, according to the company's chief financial officer, Matthew Hogan. Purdue Pharma's drug is touted as a twice-daily pain reliever, but a Los Angeles Times exposé published in May revealed that, for many patients, the drug is effective for only eight hours. This, according to the Times, means patients may take more pills than prescribed, running the risk of overdose. The pharmacokinetics of DURECT's Remoxy, Hogan noted, have been developed so that the drug's effects are "metered out over the full 12 hours."
DURECT's Remoxy may also benefit from the stigma now associated with OxyContin. Doctors may find it preferable to prescribe a drug that is both tamper- and addiction-resistant, and patients may find it preferable to take a drug without a bad reputation, Hogan said.
Recognizing that dosage is also a factor in abuse and addiction, Remoxy is being formulated in five strengths, from 5 milligrams (5 mg) to 40 mg. The 5 mg dosage would be the lowest commercially available at the present time, which is consistent with recent government recommendations that patients on extended-release opioids should "start low and go slow" with their doses. "Remoxy is attempting to be a highly responsible citizen in serving the needs of legitimate chronic pain sufferers," Hogan told The Life Sciences Report.
Though Remoxy is in the spotlight right now, DURECT's pipeline also includes a "late-stage, post-surgical pain product Posimir in Phase 3, and a new chemical entity, DUR-928, an endogenous small molecule that has shown the potential for utility in a number of liver conditions as well as acute organ injury," Hogan noted.
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Disclosures:
1) Tracy Salcedo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She owns, or her family owns, shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the article are sponsors of Streetwise Reports: DURECT Corp. Streetwise Reports does not accept stock in exchange for its services. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
3) Matt Hogan, CFO of DURECT Corp., was not paid by Streetwise Reports for providing commentary in this article. Comments and opinions expressed are his own comments and opinions. He had the opportunity to review the article for accuracy and is responsible for his comments therein.
4) Raghuram Selvaraju: Neither I, nor any member of my family, own any shares of the following companies mentioned in this article: None. Neither I personally, nor any member of my family, are paid by the following companies mentioned in this article: None. My company does not own any shares of any companies mentioned in this article, nor has my company performed investment banking services for any of the companies mentioned in this article. I was not paid by Streetwise Reports for providing commentary in this article. Comments and opinions expressed are my own comments and opinions. I had the opportunity to review the article for accuracy and am responsible for my comments therein.
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