TheraQuest’s IND for abuse deterrent strong opioid (TQ-1015) accepted by FDA
Scientists at the University of Texas at Austin have identified pathways by which a reduced-calorie diet and exercise can modify a postmenopausal woman’s risk of breast cancer. The results, presented at the American Association for Cancer Research’s Seventh Annual International Conference on Frontiers in Cancer Prevention Research, suggest that both caloric restriction and exercise affect
Full Post: Reduced-calories and exercise can modify a postmenopausal woman’s risk of breast cancer
TheraQuest Biosciences, Inc. a development stage pain management company today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (”IND”) application for TQ-1015, its abuse deterrent extended release strong opioid. TQ-1015 is being developed using Securel, TheraQuest’s proprietary abuse deterrent technology.
Najib Babul, PharmD, Chief Executive Officer of TheraQuest stated, “Sustained release opioids are the standard of care for the management of chronic pain. Unfortunately, it is easy to defeat the sustained release mechanim of such dosage forms, making them subject to drug diversion and drug abuse. The TQ-1015 dosage form is highly tamper resistant, when compared to OxyContin(R), thereby minimizing abuse by recreational drug users and drug addicts.”
TQ-1015 is a once-a-day extended release opioid analgesic for the treatment of chronic pain. It has been developed using TheraQuest’s proprietary abuse deterrent extended release drug delivery system (Securel). TQ-1015 is significantly more potent than many current oral therapies, including morphine and oxycodone. It shows robust efficacy in various animal models of acute pain, inflammatory pain and neuropathic pain. TQ-1015 will compete in the $8.3 billion U.S. opioid market.
Recent experience with extended release opioid pain relievers has shown that intentional crushing or extraction of the active ingredient from the dosage form by addicts and recreational drug users can destroy the timed-release mechanism and result in a rapid surge of drug into the bloodstream. Serious side-effects and death have been reported from such misuse.
Securel is TheraQuest’s proprietary abuse deterrent extended release technology for oral abusable drugs. Securel dosage forms cannot be easily crushed for inhalation or to obtain rapid euphoria from high blood levels when swallowed. It is also exceedingly difficult for I.V. abusers to extract the active drug from the dosage form using common solvents, including alcohol.
Pacira Pharmaceuticals, Inc., an acute care specialty pharmaceutical company, announced today that enrollment has been completed in two pivotal Phase III SIMPLE trials to evaluate the safety and efficacy of a single intraoperative administration of EXPAREL (DepoBupivacaine) for prolonged postoperative analgesia. Results from the studies in hemorrhoidectomy and in total knee arthroplasty (TKA) are expected
Full Post: Phase III studies of EXPAREL (DepoBupivacaine) from Pacira complete enrollment
Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration has granted approval for the Company’s Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 mcg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated generic equivalent of Ortho McNeil’s chronic pain treatment Duragesic. Shipment of this product has commenced.
Full Post: Teva granted FDA approval for Fentanyl transdermal system
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg. “This approval offers health care professionals an additional choice for treating moderate to
Full Post: Tapentadol hydrochloride approved for pain relief
A Phase II trial of a single intraoperative administration of Exparel (DepoBupivacaine) resulted in significantly reduced pain with activity in the first 8 to 24 hours following surgery, when pain is generally greatest, compared to conventional treatment. The results of the multicenter, randomized, double-blind study were presented in a poster at the Annual Postgraduate Assembly
Full Post: Exparel (DepoBupivacaine) shows promise in hernia repair
A review of more than 4 million insured patients with private coverage and Medicaid, published in the The Journal of Pain showed that rates of opioid use did not differ widely between non-cancer pain conditions but there were higher rates of opioid use among Medicaid patients. In this study, researchers examined general trends in prescription
Full Post: Researchers examine trends in prescription opioid use for non-cancer pain