Monthly Roundup - June 2011

Abuse-resistant Pain Drug Oxecta™ Approved With New AVERSION® Technology

Oxycodone pain drug Oxecta™ approved with added benefit to help combat opioid abuse Read more...

Lately we have heard the FDA is cracking down on misuse of opioid painkillers with their new REMs program. But what else can be done for this epidemic? In June, the FDA gave the go-ahead for Oxecta™. Formulated with the new AVERSION® technology, Oxecta™ is an immediate-release formulation of oxycodone indicated for moderate to severe pain. Would-be drugs abusers will find the new technology combats common methods of prescription opioid abuse, including IV injection, nasal snorting, and excess oral dosing. So what is AVERSION technology? With Oxecta™, pharmacy-grade gelling ingredients are added to the formulation. When the tablet is dissolved for IV abuse, the opiate is trapped and the resulting gel is too thick to draw into a syringe for injection. If the crushed pain reliever is snorted, nasal burning may occur. Oxecta™ was co-developed by Pfizer and Acura Pharmaceuticals.

FDA's Review of Painkiller Remoxy® Results in Thumbs Down Response for Pfizer

Remoxy® NDA resubmission to FDA rejected but Pfizer committed to addressing non-approval issues Read more...

The month of June has been particularly busy for opioid news. While immediate-release Oxecta™ received the FDA thumbs up, in a painful twist of fate the FDA gave the thumbs down to another oxycodone product, Remoxy® (oxycodone), both made by Pfizer. Remoxy® is an extended-release formulation indicated for moderate-to-severe pain similar to OxyContin®. Remoxy® utilizes the ORADUR® gel-cap technology designed to hinder common methods of abuse, such as crushing or dissolving to "dose-dump" the oxycodone. Pfizer has given limited clues as to the why the drug was rejected for the second time. Pfizer noted that they are working to address the issues with the FDA and are committed to being involved in the public and health safety issue of opioid abuse.

New Sunscreen Regulations Aim to Inform, Protect Consumers

Proposed FDA sunscreen regulations address testing, labeling and consumer understanding of sunscreen differences Read more...

I see you loading your beach bag with summer essentials: the latest pop tunes, frosty beverages, and those ultra-hip sunglasses. But don't forget your sunscreen, too. This month the FDA laid out new OTC sunscreen regulations to help inform consumers about the harmful effects of the sun's rays. With the new proposed regulations, sunscreens defined as "broad-spectrum" will protect against both UVA and UVB radiation, all types of sun-induced skin damage (sunburn, skin cancer, and aging), and be at least SPF 15 or higher. Sunscreens that are not broad spectrum or that have a SPF less than 15 will only be labeled as helpful in preventing sunburn. New labels are expected by next summer.

Vemurafenib and Yervoy™ Shown to Prolong Survival in Melanoma Skin Cancer

Two drugs show prolonged survival rates for advanced melanoma cases Read more...

We know that sunscreen use is important to help prevent skin cancer. But unfortunately, melanoma, if not caught early, can be one of the most aggressive and deadly skin cancers. Important news was released in June for patients who must undergo treatment for advanced melanoma. Vemurafenib and Yervoy™ (ipilumumab) have been shown to prolong survival in patients with advanced melanoma. In the BRIM3 clinical trial, vemurafenib-treated patients had a reduction in the risk of death by 63%, and a 74% reduction in disease progression compared to patients who received dacarbazine. In the second study, Yervoy™ plus dacarbazine prolonged survival by a median of 2.1 months compared to dacarbazine alone. A new drug application was submitted to the FDA in May for vemurafenib approval. Yervoy™ was approved in March of this year.

Simvastatin Maximum Dose Limits, Drug Interaction Updates Due to Muscle Damage Concern

Highest dose of simvastatin and drug interactions may lead to increased risk for muscle injury; simvastatin labels reflects concerns Read more...

If you watch TV, you've probably heard of "statins". Simvastatin (Zocor®) is a widely-prescribed cholesterol-lowering drug, also found in ezetimibe/simvastatin (Vytorin®) and niacin/simvastatin (Simcor®). Simvastatin is associated with a risk of muscle injury known as myopathy, especially when used at the highest 80 mg dose in the first year of treatment. Simvastatin combined with certain medications may also increase the risk for muscle damage, and simvastatin doses may need to be reduced. If you currently take the 80 mg dose of simvastatin or the 10/80 mg dose of Vytorin®, contact your prescriber to determine if you should remain at this dose. The simvastatin dose for Simcor® usually goes no higher than 40 mg, but still may be subject to drug interactions. Always talk to your health care provider before stopping any medications. If you take simvastatin, be sure to ask about possible drug interactions.

Posted: June 2011


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