• The maker of risperidone long-acting injection, Johnson and
Johnson Pharmaceutical Research and Development (J&JPRD), announced on
February 10 that it had received a "complete response letter" from
the Food and Drug Administration (FDA) requesting additional information about
the medication. The agency's letter was in response to the company's
supplemental application, which sought approval for the new indication of
adjunctive maintenance treatment for patients with bipolar disorder who
relapse frequently. According to the company's announcement, the agency
outlined questions that must be answered before the application can be
approved, but did not require that more clinical trials be conducted.
Risperidone long-acting injection is currently approved for the treatment
of schizophrenia.
• The FDA sent a complete response letter to Eli Lilly regarding its
application for marketing olanzapine pamoate long-acting
injection for treatment of schizophrenia. Lilly said the FDA
requested the company to provide a detailed plan on postmarketing strategies
for safety surveillance. The agency has been concerned about uncommon but
potentially severe adverse events associated with the drug in clinical trials.
These adverse events included heavy sedation, confusion, and loss of
consciousness in some cases. The FDA convened an advisory-committee meeting
about the medication a year ago and has not approved the product since then
(Psychiatric News, March 21, 2008). Lilly said it was preparing a
Risk Evaluation and Mitigation Strategy as requested and would submit it to
the agency soon.
• Schering-Plough, the company seeking regulatory approval for the
investigational antipsychotic drug asenapine sublingual
tablets, announced on January 14 that it received the FDA's complete
response letter for the new drug application. The agency asked for additional
data and proposed labeling language, but did not request that the company
conduct additional clinical trials. The company is seeking approval for its
indications as a treatment for schizophrenia and manic or mixed bipolar
disorder episodes.
• The FDA sent a warning letter to Abbott Laboratories regarding"
misbranding" information in promotional material about its
products divalproex sodium delayed-release tablets (Depakote
and Depakote ER). The letter noted that a pharmacy formulary flashcard omits
certain risk and other important information and broadens indications in the
drug information printed on the flashcard. The agency asked the company to
stop distributing the materials immediately.
• The FDA issued a follow-up announcement on January 13 about the agency's
safety review of potential neuropsychiatric risks associated with
montelukast. In March 2008 the FDA told the public that it was
closely examining clinical trial evidence for a suspected link between the
asthma/allergy drug and reports of mood changes, suicidal thoughts and
behaviors, and suicides. About nine months later, the agency said it had not
reached a definitive conclusion about the matter, and its review would
continue.
• A new drug treatment for fibromyalgia, milnacipran
hydrochloride, has been approved by the FDA, the makers Forest
Laboratories and Cypress Bioscience announced on January 14. Milnacipran is a
selective serotonin and norepinephrine reuptake inhibitor and has been tested
in two large, phase 3 clinical trials involving more than 2,000 patients. Two
other drugs, pregabalin and duloxetine, have already been approved for
treating fibromyalgia.
• U.S. Sens. Herb Kohl (D-Wis.) and Charles Grassley (R-Iowa) have proposed
new legislation to outlaw pharmaceutical companies' deals intended to keep
generic drugs off the market, according to an announcement by Kohl's office on
February 3. In recent years large pharmaceutical companies that market
brand-name "blockbuster" drugs have entered settlements with
generic drug makers over patent disputes. The results were that the generic
manufacturers would delay the marketing of generic versions of these drugs
while receiving multimillion-dollar payments or other types of business
compensation from the brand-name makers. The Federal Trade Commission has been
investigating and opposing these deals, but they have been approved by
courts.
The proposed legislation, known as the Preserve Access to Affordable
Generics Act, will prohibit such pay-off agreements between brand-name and
generic drug makers. The bill is cosponsored by Sens. Russ Feingold (D-Wis.),
Richard Durbin (D-Ill.), and Sherrod Brown (D-Ohio).
• In January Sens. Grassley and Kohl introduced a revised version of
legislation they had proposed two years before that had sought to require
public disclosure of industry gifts and payments to physicians. This Physician
Payments Sunshine Act of 2009 has lowered the threshold of gift value for
disclosure from $500 in the previous draft to $100. If passed, the bill will
require all drug, device, and biologic manufacturers to report their gifts and
payments to physicians, including travel and consulting fees, valued above
$100. A searchable database would be established by the Department of Health
and Human Services to post this information for public access.
The previous bill received support from several major pharmaceutical
companies, such as Eli Lilly, which have begun or announced plans to begin
posting payments and gifts to physicians on their company Web sites. The
latest company to get on the bandwagon was Pfizer, which said in a February 9
announcement that it would publicly disclose all gifts and payments above $500
to physicians starting in 2010.
• On January 28 a U.S. district court judge in Florida dismissed two
multimillion-dollar lawsuits against AstraZeneca alleging that its
antipsychotic drug quetiapine fumarate caused harm, including
diabetes and weight gain. These suits were brought by the first two of 15,000
plaintiffs who have filed lawsuits in the United States for similar claims
regarding the drug. The judge ruled that the lawsuits did not meet the
standards required for a case to proceed to trial.
• Eli Lilly has settled civil lawsuits and a criminal charge with the federal
government and about 30 state governments over its antipsychotic drug
olanzapine for a massive $1.42 billion, according to a January
15 Associated Press report. The company pleaded guilty to a misdemeanor
violation for promoting the drug for off-label use in patients with dementia
from September 1999 to March 2001. The civil lawsuits were related to
overcharging state Medicaid programs.
• J&JPRD announced on February 6 that it filed a new drug application
with the FDA for expanding the indication of paliperidone
tablets to schizoaffective disorder. Paliperidone is currently
approved for treating schizophrenia. The company is also seeking FDA approval
for paliperidone palmitate, the long-acting injection
formulation of paliperidone, for the treatment of schizophrenia.
• AstraZeneca has licensed a number of triple reuptake inhibitor molecules,
discovered by Mayo Clinic and Virginia Tech Intellectual Properties Inc.
scientists, that it hopes will lead to development of a new class of
medication for depression treatment. According to a February 9 company
announcement, these triple reuptake inhibitors are expected to interact with
serotonin, norepinephrine, and dopamine receptors.
Currently available antidepressants affect the reuptake receptors of either
serotonin or both serotonin and norepinephrine. The novel molecules will have
to go through preclinical animal experiments before they can be tested in
clinical trials.
• Supernus Pharmaceuticals announced on January 30 that it had begun a phase
2a clinical trial of SPN810, an investigational drug for the
treatment of conduct disorder in pediatric patients with
attention-deficit/hyperactivity disorder. It would be a randomized, open-label
trial lasting six weeks.
• NPL-2008, a formulation of fluoxetine being tested for
autistic disorder, disappointed in a phase 3 clinical trial, the company
developing the drug, Neuropharm, announced on February 18. In this trial, 158
patients with autistic disorder aged 5 to 17 were treated with either NPL-2008
or placebo for 14 weeks, but the drug did not differ significantly from
placebo in improving the symptom of repetitive behaviors. ▪