Drugs Xagena
The FDA ( Food and Drug Administration ) has approved Hysingla ER ( Hydrocodone bitartrate ), an extended-release ( ER ) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Hysingla ER has properties that are expected to reduce, but not totally prevent, abuse of the drug when chewed and then taken orally, or crushed and snorted or injected.
The tablet is difficult to crush, break or dissolve. It also forms a viscous hydrogel ( thick gel ) and cannot be easily prepared for injection.
The FDA has determined that the physical and chemical properties of Hysingla ER are expected to make abuse by these routes difficult. However, abuse of Hysingla ER by these routes is still possible. It is important to note that taking too much Hysingla ER, whether by intentional abuse or by accident, can cause an overdose that may result in death.
Hysingla ER is not approved for, and should not be used for, as-needed pain relief. Given Hysingla ER’s risks for abuse, misuse and addiction, it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management.
As a single-entity opioid, Hysingla ER does not carry the serious liver toxicity risks associated with Hydrocodone combination products containing Acetaminophen.
Strengths of Hysingla ER contain 20, 30, 40, 60, 80, 100 and 120 mg of Hydrocodone to be taken every 24 hours. Doses of 80 mg per day and higher should not be prescribed to people who have not previously taken an opioid medication ( opioid non-tolerant ). While Hysingla ER contains larger amounts of Hydrocodone compared to immediate-release Hydrocodone combination products, the range of tablet strengths of Hysingla ER is comparable to existing approved ER opioids.
The safety and effectiveness of Hysingla ER were evaluated in a clinical trial of 905 people with chronic low back pain. Additional data from studies conducted in laboratories and in people demonstrated the abuse-deterrent features of Hysingla ER for certain types of abuse ( oral, snorting and injection ).
The most common side effects of Hysingla ER are constipation, nausea, fatigue, upper respiratory tract infection, dizziness, headache and drowsiness ( somnolence ).
The FDA is requiring postmarketing studies of Hysingla ER to assess the effects of the abuse-deterrent features on the risk for abuse of Hysingla ER and the consequences of that abuse in the community.
In addition, Hysingla ER is part of the ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy ( REMS ), which requires companies to make available to health care professionals educational programs on how to safely prescribe ER/LA opioid analgesics and to provide Medication Guides and patient counseling documents containing information on the safe use, storage, and disposal of ER/LA opioids. ( Xagena )
Source : FDA, 2014
XagenaMedicine_2014
