Tag Archives: US

Collegium Pharmaceutical announces issuance of US patent for Oxycodone … -…

PBR Staff Writer Published 18 October 2013

Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that a patent has been issued by the US Patent and Trademark Office (USPTO) covering its Oxycodone DETERx formulation.

Additionally, an application has been allowed for issuance as a new patent by the USPTO.

Both patents relate to Collegium’s Oxycodone DETERx formulation and contain claims that cover the company’s product, an abuse-deterrent, extended-release oxycodone product utilizing its proprietary DETERx technology.

These are the fourth and fifth US patents related to the DETERx drug delivery technology.

Oxycodone DETERx is nearing completion of enrollment in its Phase III clinical program with a planned NDA filing in the first half of 2014.

The product has been designated fast track status by the US Food and Drug Administration (FDA).

In addition to the Phase III study to establish the safety and efficacy of the product, Collegium has executed a comprehensive development program for evaluation of the product’s abuse-deterrent properties consistent with the FDA‘s recently-issued Guidance, ‘Abuse-Deterrent Opioids – Evaluation and Labeling’.

Collegium CEO Michael Heffernan noted these newly issued claims covering the company’s platform technology continue to strengthen and expand its overall patent coverage for Oxycodone DETERx.

“We are continuing to focus on the prosecution of additional patents that support our lead product and the DETERx® technology in both the U.S. and internationally,” Heffernan added.

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Collegium Pharmaceutical announces issuance of US patent for Oxycodone … -…

Aglukkaq asks for US help to control oxycodone

Months after the federal health minister ignored expert advice and approved a generic version of the much-abused prescription drug oxycodone, she has now asked for assistance from the United States in controlling the drug’s use.

Federal Health Minister Leona Aglukkaq sent a letter on Mar. 12 to Gil Kerlikowske of the Office of National Drug Policy and Dr. Margaret Hamburg, commissioner of the US Food and Drug Administration (FDA), asking for their assistance in working together on the oxycodone (OxyContin) issue.

In the letter, Aglukkaq specifically makes reference to the dangers of the generic version of the drug she approved for manufacture in November 2012, writing that she remains “particularly concerned with the potential for abuse and diversion of pharmaceutical drugs, including generic versions of OxyContin.”

“As neighbours, we have a shared responsibility to require appropriate controls in our respective jurisdictions, for the health and safety of our communities and also to reduce risks of cross-border trafficking,” she states in the letter.

“Preventing the abuse and diversion of pharmaceutical drugs is an area where cooperation between our two countries would be valuable in helping to achieve our common objectives. To this end, I propose that our officials work together to develop joint evidence-based guidance on abuse deterrence that could be used on both sides of the border.”

Aglukkaq made the controversial decision to approve the manufacture of generic forms of oxycodone, despite urgings from every provincial and territorial health minister to, at the very least, delay the decision until more research had been conducted.

Federal NDP Health Critic Libby Davies writes in an email that by deciding to approve generic oxycodone, “the Health Minister has abandoned another complex health issue and left the provinces to deal with the consequences.”

“We heard the warnings from provincial ministers of health and dozens of physicians have warned that its release could gravely increase abuse of the drug, and pose a significant public health risk,” Davies writes in an email.

Meanwhile, across the border, the FDA is waiting for more information on safety and effectiveness before approving new generic forms of oxycodone.

“FDA does not intend to approve the marketing of generic versions of the original formulation of OxyContin until the agency determines whether the original formulation was withdrawn for reasons of safety or effectiveness,” states FDA spokesperson Lisa Kubaska in an email.

Aglukkaq’s decision to approve the generic oxycodone created waves across the border.

On Nov. 21, 2012, Montana Attorney General Steve Bullock wrote to the minister, asking her to “respectfully reconsider” approving the manufacture of generic oxycodone. “I have concerns that allowing easier-to-abuse oxycodone in Canada could undo some of the work that both Canadian and U.S. government and community leaders have accomplished in combating this epidemic,” the letter stated.

That same month, the US Office of National Drug Control Policy sent out an alert regarding the increased risk of the cross-border trafficking of generic oxycodone after six generic pharmaceutical companies were licensed to manufacture the drug. “The potential exists for diversion into the United States because the old formulations, which are easier to abuse, are unavailable in the United States,” the alert stated.

Canada currently ranks as the second largest consumer of prescription opioids in the world behind the US, while deaths from oxycodone increased by 416% between 1999 and 2004.

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Aglukkaq asks for US help to control oxycodone – CMAJ

Aglukkaq asks US to join forces against oxycodone abuse

Health Minister Leona Aglukkaq has written the U.S. Food and Drug Administration to ask if the two countries can work together to address abuse of the powerful painkiller oxycodone.Health Minister Leona Aglukkaq has written the U.S. Food and Drug Administration to ask if the two countries can work together to address abuse of the powerful painkiller oxycodone. (Sean Kilpatrick/Canadian Press)

The federal health minister has written the U.S. Food and Drug Administration to ask if the two countries can work together to address the abuse of the powerful painkiller oxycodone, also known by the brand name OxyContin.

In the letter, Leona Aglukkaq, writes, “I propose our officials work together to develop joint evidence-based guidance on abuse deterrence that could be used on both sides of the border.”

In particular, sources in Aglukkaq’s office say she is hoping to clearly define, with the FDA, whether or not a drug is “tamper-resistant” or “tamper-proof.”

OxyContin was pulled from the market by its maker, Purdue Pharma, last year over cocerns about abuse of the drug and replaced with a new pill called OxyNEO. The new drug has a different coating that makes it harder to crush. The old pill could be crushed simply by chewing it, releasing a powerful, morphine-like high.

People who work with addicts say OxyNeo isn’t tamper-proof, but it is more difficult to abuse.

Generic version approved

Last fall, Ottawa faced a lot of pressure from some provincial health ministers and police associations arguing against allowing drug companies to manufacture generic versions of the original OxyContin pill.

But Ottawa did say yes to half a dozen generic drug companies, stating the drug is needed by patients with chronic pain.

In her letter to the FDA, Aglukkaq said she’s looking to balance the importance of allowing access to effective pain medication with the need to mitigate the risk of diversion and abuse.

“As neighbours, we have a shared responsibility to require appropriate controls in our respective jurisdictions, for the health and safety of our communities and also to reduce risks of cross-border trafficking,” Aglukkaq wrote.

The letter was sent to Gil Kerlikowske, from the Office of National Drug Policy, and Dr. Margaret Hamburg, the commissioner with the U.S. Food and Drug Administration.

FDA Letter (PDF)
FDA Letter (Text)


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Aglukkaq asks US to join forces against oxycodone abuse – CBC.ca