On September 1, the
Food and Drug Administration (FDA) warned the public that serious allergic
reactions have been reported with the use of the antipsychotic Saphris (asenapine maleate). A search
of the FDA's Adverse Event Reporting System database identified 52 cases of
Type I hypersensitivity reactions linked to Saphris
use. The hypersensitivity reactions included anaphylaxis, angioedema,
hypotension, tachycardia, swollen tongue, dyspnea,
wheezing, and rash. In several cases, these reactions occurred after
the first dose.
The Contraindications, Warning and Precautions, Adverse
Reactions, and Patient Counseling Information sections of Saphris's
label have been revised to include information about this risk and to inform
health care professionals that Saphris should not be
used in patients with a hypersensitivity to the drug. The FDA advised health
care professionals to educate patients on the symptoms of an allergic reaction
and to seek help immediately if they experience any of these symptoms while
The FDA's drug-safety communication regarding Saphris is posted at <www.fda.gov/Drugs/DrugSafety/ucm270243.htm>.
Transcept Pharmaceuticals announced September 14 that it is working to resolve issues
with the FDA concerning its new drug application (NDA) seeking approval of Intermezzo
sublingual tablet) for use as needed for insomnia treatment when
a middle of the night awakening is followed by difficulty returning to sleep. Transcept received a complete response letter from the FDA
in July regarding resubmission of the Intermezzo NDA. In a September 14 meeting
with Transcept, the FDA generally agreed with a Transcept proposal to reduce the recommended Intermezzo
dose for women from 3.5 mg to 1.75 mg and to keep the recommended Intermezzo
dose for men at 3.5 mg. The proposal also includes new instructions
stating that Intermezzo should be taken only if patients have at least four
hours of bedtime remaining and that patients should refrain from driving for at
least one hour after arising and until five hours after taking the medication.
Based on discussion with the FDA, Transcept
does not plan to conduct additional studies prior to resubmitting the
Intermezzo NDA. The FDA has informed Transcept that
if the resubmission is adequately concise in summarizing morning zolpidem levels and shows evidence that the levels are safe
given the proposed labeling, it may be able to consider the resubmission as a
two-month, Class 1 review under FDA guidelines.
Transcept and Purdue Pharmaceutical
Products have entered into a collaborative agreement for development and
commercialization of Intermezzo in the United States.
Pharmaceuticals announced on August 31 that it had received final FDA approval
for its abbreviated new drug application for tramadol
hydrochloride extended-release tablets, 100 mg, 200 mg, and 300
mg strengths. Tramadol ER is a centrally acting
synthetic analgesic in an extended-release formulation (the generic equivalent
to Ortho-McNeil's Ultram ER tablets) and is indicated
for moderate to moderately severe chronic pain in adults who require
around-the-clock pain treatment for an extended period.
On September 7, the U.S. Drug
Enforcement Administration (DEA) used its emergency scheduling authority to
temporarily control three synthetic stimulants (mephedrone; 3,4 methylenedioxypyrovalerone; and methylone).
The DEA said the action was necessary to protect the public from
the hazard posed by these dangerous chemicals. This action will make possessing
and selling these chemicals or the products that contain them illegal for at
least one year while the DEA and the Department of Health and Human Services
further study whether these chemicals should be permanently controlled.
A Notice of Intent to temporarily control the stimulants was
published in the Federal Register
September 7. In the near future the DEA intends to publish in the Federal
Register a Final Order to temporarily control these chemicals for at
least 12 months, with the possibility of a six-month extension. The final order
will designate these chemicals as Schedule I substances, the most restrictive
category, which is reserved for unsafe, highly abused substances with no
currently accepted medical use in the United States.
Register notice is posted at <www.deadiversion.usdoj.gov/fed_regs/rules/2011/fr0908.htm>.
On September 6, Sagent Pharmaceuticals announced FDA approval of its haloperidol
injection, an antipsychotic medication. Sagent's
haloperidol will be offered in 5 mg per mL
single-dose and 50 mg per 10 mL multidose,
latex-free vials. As with all products in Sagent's
portfolio, haloperidol features the company's PreventIV
Measures color-coded packaging and labeling designed to aid in reducing
medication errors. Sagent expects to launch the
product in the fourth quarter of the year. Haloperidol is indicated for use in
schizophrenia and for control of tics and vocal utterances of Tourette's disorder.
FDA informed health care professionals and patients on August 24 that the
antidepressant Celexa (citalopram hydrobromide (also marketed in generic formulations) should no longer be used at doses greater than 40 mg per day because it can cause prolongation of the QT
interval and lead to abnormal heart rhythm, including Torsade
de Pointes. Studies did not show a benefit in the treatment of depression at
daily doses higher than 40 mg. Previously, the citalopram drug label stated that certain patients may
require a dose of 60 mg per day.
The citalopram label has been revised
to include the new dosage and usage recommendations, as well as information
about the potential for QT interval prolongation and Torsade
Janssen Pharmaceuticals announced
August 26 that the FDA has approved Nucynta
ER, an oral analgesic taken twice daily, for management of
moderate to severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period.
Johnson & Johnson
Pharmaceutical Research and Development and Grünenthal,
a privately owned pharmaceutical company based in Germany, conducted the
double-blind, randomized, active and/or placebo-controlled phase 3 studies that
evaluated the efficacy and safety of Nucynta ER for
treatment of moderate to severe chronic low back pain and painful diabetic peripheral neuropathy. Safety was also evaluated in more than 1,100 patients with moderate to
severe chronic pain over a one-year period.