Re: Farmas USA
El artículo es un poco sensacionalista porque empieza el rollo de los tumores cuando, en realidad, fueron en ratas y están descartados en humanos. La FDA la ha aprobado y punto, y apuesto a que la EMA también lo hará. Los problemas aquí vienen de que el producto coloca, así que hay que adaptarse a una normativa de comercialización y demás. A todo esto, no hay que olvidar que los productos adelgazantes tienen una larga tradición anfetamínica. Si coloca, igual se vende aún más. :)
El problema es el tiempo y lo que ello puede afectar a la cotización.
Aquí están los datos que he encontrado
Lorcaserin ((R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzepine
hydrochloride hemihydrate) is a new chemical entity which has central
nervous system hallucinogenic properties. Lorcaserin is a serotonin
receptor agonist, at the 5HT2C and 5HT2A receptor
subtypes. Lorcaserin was approved by the Food and Drug Administration
(FDA) on June 27, 2012, as an addition to a reduced-calorie diet and
exercise, for chronic weight
HHS described a human abuse potential study in recreational drug
abusers of psychedelic drugs and CNS depressants, in which lorcaserin
and the comparator drugs zolpidem (Schedule IV) and ketamine (Schedule
III) produced significant increases on positive subjective measures
(visual analog scales (VAS)) for ``high'' and ``good drug effects as
well as an increase on the VAS for ``hallucinations. The incidence of
euphoria following lorcaserin administration in the human abuse
potential study is similar to that reported following zolpidem
(Schedule IV) administration (13-16%) and lower than that following
ketamine (Schedule III) administration (50%).
HHS stated that acutely, lorcaserin decreases locomotor activity in
rats. Tolerance does develop to this effect, because after 21 days,
lorcaserin does not affect the locomotor activity of the rats. DEA
further notes that a study showed that food intake in rats was reduced
after a single administration of lorcaserin. The doses administered
were 3, 6, 12, and 24 mg/kg. Lorcaserin decreased the cumulative food
intake at 2, 4, 6, and 22 hours.
HHS stated that acutely, lorcaserin decreases locomotor activity in
rats. Tolerance does develop to this effect, because after 21 days,
lorcaserin does not affect the locomotor activity of the rats. DEA
further notes that a study showed that food intake in rats was reduced
after a single administration of lorcaserin. The doses administered
were 3, 6, 12, and 24 mg/kg. Lorcaserin decreased the cumulative food
intake at 2, 4, 6, and 22 hours.
According to
HHS' review, there were two clinical studies conducted to determine the
ability of lorcaserin to induce physical dependence. The patients in
these studies were obese and lorcaserin was administered for 4 and 12
weeks prior to drug discontinuation. Upon lorcaserin discontinuation,
there were no signs of changes in mood, food interest, or body weight.
Discontinuation of lorcaserin administration to animals also did not
produce typical withdrawal symptoms. However, according to HHS, the
ability of lorcaserin to produce hallucinations, euphoria, and positive
subjective responses at supratherapeutic doses is suggestive of its
potential to produce psychic dependence.
Conclusion: Based on consideration of the scientific and medical
evaluation conducted by HHS and its recommendation, and after
considering its own eight-factor analysis, DEA has determined that
these facts and all relevant data constitute substantial evidence of
potential for abuse of lorcaserin. As such, DEA hereby proposes to
schedule lorcaserin as a controlled substance under the CSA.
Proposed Determination of Appropriate Schedule
The CSA establishes five schedules of controlled substances known
as Schedules I, II, III, IV, and V. The statute outlines the findings
required in placing a drug or other substance in any schedule. 21
U.S.C. 812(b). After consideration of the analysis and recommendation
of the Assistant Secretary for Health of HHS and review of all
available data, the Administrator of DEA, pursuant to 21 U.S.C. 812(b),
finds that:
(1) Lorcaserin has a low potential for abuse relative to the drugs
or other substances in Schedule III. The overall abuse potential of
lorcaserin is comparable to the Schedule IV substances;
(2) Lorcaserin has a currently accepted medical use in treatment in
the United States. Lorcaserin was approved for marketing by FDA as an
addition to a reduced-calorie diet and exercise, for chronic weight
management; and
(3) Abuse of lorcaserin may lead to limited psychological
dependence relative to the drugs or other substances in Schedule III.
This finding is based on the ability of lorcaserin to produce positive
subjective effects at supratherapeutic doses.
Based on these findings, the Administrator of DEA concludes that
lorcaserin, including its salts, isomers, and salts of isomers whenever
the existence of such salts, isomers, and salts of isomers is possible,
warrants control in Schedule IV of the CSA (21 U.S.C. 812(b)(4)).
Requirements for Handling Lorcaserin
If this rule is finalized as proposed, lorcaserin would be subject
to CSA regulatory controls and administrative, civil and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing and exporting of a Schedule IV controlled substance,
including the following:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with lorcaserin, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with lorcaserin, would need to be registered to conduct such
activities pursuant to 21 U.S.C. 822 and in accordance with 21 CFR Part
1301.
Security. Lorcaserin would be subject to Schedules III-V security
requirements and would need to be manufactured, distributed, and stored
pursuant to 21 U.S.C. 823 and in accordance with 21 CFR 1301.71,
1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c),
1301.76, and 1301.77.
Labeling and Packaging. All labels and labeling for commercial
containers of lorcaserin which are distributed on or after finalization
of this rule would need to be in accordance with 21 CFR 1302.03-
1302.07, pursuant to 21 U.S.C. 825.
Inventory. Every registrant required to keep records and who
possesses any quantity of lorcaserin would be required to keep an
inventory of all stocks of lorcaserin on hand pursuant to 21 U.S.C. 827
and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Every
registrant who desires registration in Schedule IV for lorcaserin would
be required to conduct an inventory of all stocks of the substance on
hand at the time of registration.
Records. All registrants would be required to keep records pursuant
to 21 U.S.C. 827 and in accordance with 21 CFR 1304.03, 1304.04,
1304.21, 1304.22, and 1304.23.
Prescriptions. All prescriptions for lorcaserin or prescriptions
for products containing lorcaserin would be required to be issued as a
controlled substance pursuant to 21 U.S.C. 829 and in accordance with
21 CFR 1306, including but not limited to 21 CFR 1306.03-1306.06,
1306.08, 1306.09, and 1306.21-1306.27.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
